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Fibrosarcomas- The Myth Dissolved



 
 
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  #1  
Old June 28th 04, 11:57 PM
Osiris Virus
external usenet poster
 
Posts: n/a
Default Fibrosarcomas- The Myth Dissolved

http://www.ncbi.nlm.nih.gov/entrez/q..._uids=14621215

***

J Am Vet Med Assoc. 2003 Nov 1;223(9):1283-92.


Multicenter case-control study of risk factors associated with
development of vaccine-associated sarcomas in cats.

Kass PH, Spangler WL, Hendrick MJ, McGill LD, Esplin DG, Lester S,
Slater M, Meyer EK, Boucher F, Peters EM, Gobar GG, Htoo T, Decile K.

Department of Population Health and Reproduction, School of Veterinary
Medicine, University of California, Davis, CA 95616, USA.

OBJECTIVE: To determine whether particular vaccine brands, other
injectable medications, customary vaccination practices, or various
host factors were associated with the formation of vaccine-associated
sarcomas in cats. DESIGN: Prospective multicenter case-control study.
ANIMALS: Cats in the United States and Canada with soft tissue
sarcomas or basal cell tumors. PROCEDU Veterinarians submitting
biopsy specimens from cats with a confirmed diagnosis of soft tissue
sarcoma or basal cell tumor were contacted for patient medical
history. Time window statistical analyses were used in conjunction
with various assumptions about case definitions. RESULTS: No single
vaccine brand or manufacturer within antigen class was found to be
associated with sarcoma formation. Factors related to vaccine
administration were also not associated with sarcoma development, with
the possible exception of vaccine temperature prior to injection. Two
injectable medications (long-acting penicillin and methyl prednisolone
acetate) were administered to case cats more frequently than to
control cats. CONCLUSIONS AND CLINICAL RELEVANCE: Findings do not
support the hypotheses that specific brands or types of vaccine within
antigen class, vaccine practices such as reuse of syringes,
concomitant viral infection, history of trauma, or residence either
increase or decrease the risk of vaccine-associated sarcoma formation
in cats. There was evidence to suggest that certain long-acting
injectable medications may also be associated with sarcoma formation.

Publication Types:
Multicenter Study

PMID: 14621215 [PubMed - indexed for MEDLINE]
  #2  
Old June 29th 04, 12:23 AM
Cheryl
external usenet poster
 
Posts: n/a
Default

In the fine newsgroup "rec.pets.cats.health+behav",
(Osiris Virus) artfully composed this
message within
. com on 28 Jun
2004:

RESULTS: No single
vaccine brand or manufacturer within antigen class was found to
be associated with sarcoma formation. Factors related to vaccine
administration were also not associated with sarcoma
development, with the possible exception of vaccine temperature
prior to injection.


Did they state at what temperature it becomes a risk? Also, is this
study widely published among the vet community?

Two injectable medications (long-acting
penicillin and methyl prednisolone acetate) were administered to
case cats more frequently than to control cats. CONCLUSIONS AND
CLINICAL RELEVANCE: Findings do not support the hypotheses that
specific brands or types of vaccine within antigen class,
vaccine practices such as reuse of syringes, concomitant viral
infection, history of trauma, or residence either increase or
decrease the risk of vaccine-associated sarcoma formation in
cats. There was evidence to suggest that certain long-acting
injectable medications may also be associated with sarcoma
formation.

Thanks for posting this. There needs to be many many more studies
WRT vaccinations, sarcomas, and how long vaccinations truly protect
against these virii and disease. I'd gladly pay higher vet bills if
I knew part of the money would go toward studies such as this.

Publication Types:
Multicenter Study

PMID: 14621215 [PubMed - indexed for MEDLINE]




--
Cheryl
  #3  
Old June 29th 04, 12:23 AM
Cheryl
external usenet poster
 
Posts: n/a
Default

In the fine newsgroup "rec.pets.cats.health+behav",
(Osiris Virus) artfully composed this
message within
. com on 28 Jun
2004:

RESULTS: No single
vaccine brand or manufacturer within antigen class was found to
be associated with sarcoma formation. Factors related to vaccine
administration were also not associated with sarcoma
development, with the possible exception of vaccine temperature
prior to injection.


Did they state at what temperature it becomes a risk? Also, is this
study widely published among the vet community?

Two injectable medications (long-acting
penicillin and methyl prednisolone acetate) were administered to
case cats more frequently than to control cats. CONCLUSIONS AND
CLINICAL RELEVANCE: Findings do not support the hypotheses that
specific brands or types of vaccine within antigen class,
vaccine practices such as reuse of syringes, concomitant viral
infection, history of trauma, or residence either increase or
decrease the risk of vaccine-associated sarcoma formation in
cats. There was evidence to suggest that certain long-acting
injectable medications may also be associated with sarcoma
formation.

Thanks for posting this. There needs to be many many more studies
WRT vaccinations, sarcomas, and how long vaccinations truly protect
against these virii and disease. I'd gladly pay higher vet bills if
I knew part of the money would go toward studies such as this.

Publication Types:
Multicenter Study

PMID: 14621215 [PubMed - indexed for MEDLINE]




--
Cheryl
  #4  
Old June 29th 04, 06:18 AM
-L. :
external usenet poster
 
Posts: n/a
Default

(Osiris Virus) wrote in message . com...
http://www.ncbi.nlm.nih.gov/entrez/q..._uids=14621215

***

J Am Vet Med Assoc. 2003 Nov 1;223(9):1283-92.


snip

I wonder what vaccine manufacturer funded this study, LOL...

-L.
  #5  
Old June 29th 04, 06:18 AM
-L. :
external usenet poster
 
Posts: n/a
Default

(Osiris Virus) wrote in message . com...
http://www.ncbi.nlm.nih.gov/entrez/q..._uids=14621215

***

J Am Vet Med Assoc. 2003 Nov 1;223(9):1283-92.


snip

I wonder what vaccine manufacturer funded this study, LOL...

-L.
  #6  
Old June 29th 04, 01:07 PM
PawsForThought
external usenet poster
 
Posts: n/a
Default

From: (-L.


http://www.ncbi.nlm.nih.gov/entrez/q...db=pubmed&dopt
=Abstract&list_uids=14621215

***

J Am Vet Med Assoc. 2003 Nov 1;223(9):1283-92.


snip

I wonder what vaccine manufacturer funded this study, LOL...


Speaking of vaccine manufacturers, here's some more food for thought:

http://www.fda.gov/foi/warning_letters/g4602d.htm

March 31, 2004
HAND DELIVERED
WARNING LETTER
Ref. RAN 2004-06

Mr. E. Thomas Corcoran, President
Fort Dodge Animal Health, a Division of Wyeth, Inc.
9401 Indian Creek Parkway, Suite 1500
Overland Park, KS 66210

Dear Mr. Corcoran:

On December 1-12, 2003 Food and Drug Administration (FDA) Investigators
performed an inspection of your veterinary pharmaceutical manufacturing
operation known as Fort Dodge Laboratories, Inc., located at 800 5th Street,
N.W., Fort Dodge, Iowa 50501. This inspection revealed serious deviations from
the current Good Manufacturing Practice (cGMP) regulations, Title 21, Code of
Federal Regulations, Parts 210 and 211 (21 CFR 210 and 211). These deviations
cause your drug products to be adulterated within the meaning of Section
501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Section
501(a)(2)(B) of the Act requires that the methods used in, or the facilities or
controls used for, the manufacture, processing, packing, and holding of drugs
conform with cGMP to assure that such drugs meet the requirements of the Act as
to safety, and have the identity and strength, and meet the quality and purity
characteristics, which they purport or are represented to possess.

Deviations observed during the establishment inspection include, but are not
limited to the following:

1. The Quality Assurance Auditing Staff failed to fully follow established
Standard Operating Procedure (SOP) 81-003-14 with regard to the auditing of
personnel working in the aseptic core. The audits performed have not identified
deficiencies in the systems designed to prevent microbial contamination of drug
products purported to be sterile. [21 CFR 211.22(d)]

2. Employees working in the sterile manufacturing area and sterility suite lack
appropriate training in aseptic techniques and aseptic conduct. In addition,
these employees have failed to follow established SOPS designed to prevent
microbiological contamination of drug products purported to be sterile as
evidenced by FDA’s numerous inspectional observations. The inspectional
observations include an employee entering the Class [redacted] filling suite
with exposed skin between the hood and mask. This same employee was observed to
be wearing safety glasses when the Gowning Procedures for the Parenteral

Sterile Filling Area SOP 14-011-12 specifically states in bold letters that
safety goggles are to be worn. Forceps used to remove fallen vials were brought
out of the Class [redacted] room area into the Class [redacted] area and back
into the Class [redacted] area. Employees in room [redacted] aseptic filling
room exhibited inappropriate aseptic conduct as evidenced by the observation of
rapid movement throughout the Class [redacted] filling room. An operator was
observed to reach over uncovered vials being loaded onto the turntable while he
was removing vials that had fallen over. The plastic curtains that surround the
Class [redacted] area, which are intended to protect the product from
contamination, were displaced leaving gaps which could affect air flow in the
Class e area. An operator in the sterile tilling suite was observed spraying
her fingertips with isopropyl alcohol before collecting personnel environmental
monitoring samples from her fingertips. The above-referenced observations
reveal significant problems in the training of the employees who perform
activities in the sterile core. [21 CFR 211.25(a), 21 CFR 211.28(a), and 21 CFR
211.113(b)]

3. The environmental monitoring systems in the small volume parenteral
manufacturing and filling areas are deficient in that your firm has not
performed a scientific assessment to identify appropriate environmental
monitoring sampling sites during the actual manufacturing and sterile filling
operations that could pose the most microbiological risk to the products
manufactured. Inspectional observations include failure to perform air sampling
in the area near the vial turntable to assess the condition of the air during
manual loading of vials. Environmental monitoring of personnel was not
performed immediately after a significant intervention into the Class
[redacted] area. Equipment such as forceps, carts, and tools used during the
filling operation a was observed being sprayed directly over the [redacted]
located in the Class [redacted] area during the media fill. This occurred after
intervention through the plastic curtains that surround the Class [redacted]
area and after Rodac sampling of the plastic curtains was performed.
Environmental monitoring for viable organisms in the manufacturing area is done
in the center of the room at times when there is no activity in the room. [21
CFR 211.113(b)]

4. No evaluation has been performed to show the adequacy and efficacy of the
cleaning and disinfection process used in parenteral filling room [redacted] as
specified by SOP 14-014-08 [21 CFR 211.42(c)(10)(v)].

5. Investigations of a batch failure or any of its components processed in the
aseptic processing area did not extend to other drug products that may have
been associated with a specific failure or discrepancy. The heat exchanger used
in the Small Volume Parenteral manufacturing rooms [redacted] and [redacted]
was found to be contaminating the water for injection (WFI) with bacteria. The
failure investigation did not extend to reviewing the possible impact on other
previously manufactured drug products. In addition, the heat exchanger
continued to be used to manufacture other parenteral products after the
equipment was identified as being contaminated. Furthermore, the filter
integrity test procedure outlined in SOP 14-177-01 does not specify a limit on
the number of times a filter can be flushed or rewetted. [21 CFR 211.192 and 21
CFR 211.42(c)(10)(vi)]

6. All established procedures for production and process control for
manufacturing of pharmaceuticals are not followed and documented at the time of
performance. For example, during the filling procedures for Factrel®, Lot
431334, the [redacted] air sampler was not placed in the location designated by
SOP 14-017-21. In the Package and Product Integrity Examination established in
SOP 14-059-10 specifies that each vial will be visually examined to assure the
integrity of the filled and sealed products. During the establishment
inspection, one of the analysts assigned to perform the visual inspection was
observed to look away from the line on several occasions thus allowing other
vials to pass the inspection site. [21 CFR 211.100(b)]

It is our assessment that the deviations listed above and discussed with your
firm’s senior management are significant and are a reflection of weaknesses
in one or more of the systems designed to control the manufacture of veterinary
pharmaceuticals purported to be sterile.

The cGMP deviations noted during the December 2003 establishment inspection,
where the firm’s employees failed to follow Standard Operating Procedures, do
not appear to be isolated events. On November 12, 1999, your firm recalled a
lot of Synovex Plus (Trenbolone Acetate and Estradiol Acetate) because it was
released for distribution despite failing content uniformity testing. On or
about April 30, 2002, Fort Dodge Animal Health sent a letter to FDA’s Center
for Veterinary Medicine's (CVM), Division of Compliance requesting the rework
of one lot of Synovex H (Testosterone Propionate, Estradiol Benzoate) because
the release assay showed that the product potency was approximately 10% below
the labeled claims.

It should also be noted that similar rework requests were made for products
manufactured at the Fort Dodge Laboratories, Riverside Drive location. On or
about April 15, 2002, Fort Dodge Animal Health sent a letter to CVM’s
Division of Compliance requesting rework of one lot of Torbutrol Tablets
(Butorphanol Tartrate) because the tablets failed average weight testing. The
firm had made a similar request during November 1999 to rework a previous lot
of Torbutrol Tablets for a similar failure. On or about May 2, 2002, Fort Dodge
Animal Health sent a letter to CVM’s Division of Compliance requesting rework
of one lot of EtoGesic Tablets (Etodolac) due to tablet chipping and cracking.
The firm made a similar request for three other lots of EtoGesic Tablets on or
about May 30, 2001.

The commonality regarding the above referenced reworks is that the firm’s
requests stated that personnel training and experience were factors in the
product quality as well as failure to follow Standard Operating Procedures.

We reviewed your firm's’s response to the FDA-483 observations dated January
14, 2004 and signed by Michael Mlodzik, Associate Director, Pharmaceutical
Regulatory Affairs. We acknowledge that your firm has made some changes and
provided additional training to your Quality Assurance Auditing Staff as well
as to the employees that work in the sterile core in response to FDA’s
inspectional observations. Your firm has revised twenty-two SOPS associated
with the sterile core operation, personnel aseptic conduct, environmental
monitoring, microbial testing for the water for injection (WFI) system, filter
integrity testing, packaging, and product integrity visual examination. Several
of the aforementioned SOPS are viewed as critical to achieve cGMP compliance
for an aseptic pharmaceutical manufacturing facility. The proposed corrections
will be verified during the next establishment inspection.

The above identification of violations is not intended to be an all-inclusive
list of deficiencies at your facility. It is your responsibility to assure
adherence with each requirement of the Act and its implementing regulations.
Deviations from the cGMP regulations were noted on a FDA Form 483 that was
issued to and discussed with Dr. Vickie L. Hall, M.S., Ph.D., Vice President of
the Iowa Operations and other members of the staff at the Fort Dodge location
during a close-out meeting held on the final day of the inspection. A copy of
the FDA Form 483 is enclosed for your information.

You should know that these violations might result in FDA taking regulatory
action without further notice to you. These actions include, but are not
limited to, seizure and/or injunction. Also, other federal agencies are
informed about certain Warning Letters issued by FDA so they may consider this
information when awarding government contracts.

Please inform this office, in writing, within fifteen (15) working days of
receiving this letter of the steps you are taking to correct these deviations.
If the corrective actions are going to extend past fifteen days, please include
in your response a detailed and specific timeline for the completion of your
actions. In addition, please contact the District Office to schedule a meeting
regarding your response to this letter. The written response should be
delivered at the meeting. At this meeting, it is anticipated that discussion
will be held regarding corrective actions taken by your firm, the effectiveness
of these actions, and the status of sterile drug products manufactured under
the conditions found during the inspection.

You should direct your reply to Ralph J. Gray, Compliance Officer, at the above
address.


Sincerely,
________
See my cats: http://community.webshots.com/album/56955940rWhxAe
Raw Diet Info: http://www.holisticat.com/drjletter.html
http://www.geocities.com/rawfeeders/ForCatsOnly.html
Declawing Info: http://www.wholecat.com/articles/claws.htm
  #7  
Old June 29th 04, 01:07 PM
PawsForThought
external usenet poster
 
Posts: n/a
Default

From: (-L.


http://www.ncbi.nlm.nih.gov/entrez/q...db=pubmed&dopt
=Abstract&list_uids=14621215

***

J Am Vet Med Assoc. 2003 Nov 1;223(9):1283-92.


snip

I wonder what vaccine manufacturer funded this study, LOL...


Speaking of vaccine manufacturers, here's some more food for thought:

http://www.fda.gov/foi/warning_letters/g4602d.htm

March 31, 2004
HAND DELIVERED
WARNING LETTER
Ref. RAN 2004-06

Mr. E. Thomas Corcoran, President
Fort Dodge Animal Health, a Division of Wyeth, Inc.
9401 Indian Creek Parkway, Suite 1500
Overland Park, KS 66210

Dear Mr. Corcoran:

On December 1-12, 2003 Food and Drug Administration (FDA) Investigators
performed an inspection of your veterinary pharmaceutical manufacturing
operation known as Fort Dodge Laboratories, Inc., located at 800 5th Street,
N.W., Fort Dodge, Iowa 50501. This inspection revealed serious deviations from
the current Good Manufacturing Practice (cGMP) regulations, Title 21, Code of
Federal Regulations, Parts 210 and 211 (21 CFR 210 and 211). These deviations
cause your drug products to be adulterated within the meaning of Section
501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Section
501(a)(2)(B) of the Act requires that the methods used in, or the facilities or
controls used for, the manufacture, processing, packing, and holding of drugs
conform with cGMP to assure that such drugs meet the requirements of the Act as
to safety, and have the identity and strength, and meet the quality and purity
characteristics, which they purport or are represented to possess.

Deviations observed during the establishment inspection include, but are not
limited to the following:

1. The Quality Assurance Auditing Staff failed to fully follow established
Standard Operating Procedure (SOP) 81-003-14 with regard to the auditing of
personnel working in the aseptic core. The audits performed have not identified
deficiencies in the systems designed to prevent microbial contamination of drug
products purported to be sterile. [21 CFR 211.22(d)]

2. Employees working in the sterile manufacturing area and sterility suite lack
appropriate training in aseptic techniques and aseptic conduct. In addition,
these employees have failed to follow established SOPS designed to prevent
microbiological contamination of drug products purported to be sterile as
evidenced by FDA’s numerous inspectional observations. The inspectional
observations include an employee entering the Class [redacted] filling suite
with exposed skin between the hood and mask. This same employee was observed to
be wearing safety glasses when the Gowning Procedures for the Parenteral

Sterile Filling Area SOP 14-011-12 specifically states in bold letters that
safety goggles are to be worn. Forceps used to remove fallen vials were brought
out of the Class [redacted] room area into the Class [redacted] area and back
into the Class [redacted] area. Employees in room [redacted] aseptic filling
room exhibited inappropriate aseptic conduct as evidenced by the observation of
rapid movement throughout the Class [redacted] filling room. An operator was
observed to reach over uncovered vials being loaded onto the turntable while he
was removing vials that had fallen over. The plastic curtains that surround the
Class [redacted] area, which are intended to protect the product from
contamination, were displaced leaving gaps which could affect air flow in the
Class e area. An operator in the sterile tilling suite was observed spraying
her fingertips with isopropyl alcohol before collecting personnel environmental
monitoring samples from her fingertips. The above-referenced observations
reveal significant problems in the training of the employees who perform
activities in the sterile core. [21 CFR 211.25(a), 21 CFR 211.28(a), and 21 CFR
211.113(b)]

3. The environmental monitoring systems in the small volume parenteral
manufacturing and filling areas are deficient in that your firm has not
performed a scientific assessment to identify appropriate environmental
monitoring sampling sites during the actual manufacturing and sterile filling
operations that could pose the most microbiological risk to the products
manufactured. Inspectional observations include failure to perform air sampling
in the area near the vial turntable to assess the condition of the air during
manual loading of vials. Environmental monitoring of personnel was not
performed immediately after a significant intervention into the Class
[redacted] area. Equipment such as forceps, carts, and tools used during the
filling operation a was observed being sprayed directly over the [redacted]
located in the Class [redacted] area during the media fill. This occurred after
intervention through the plastic curtains that surround the Class [redacted]
area and after Rodac sampling of the plastic curtains was performed.
Environmental monitoring for viable organisms in the manufacturing area is done
in the center of the room at times when there is no activity in the room. [21
CFR 211.113(b)]

4. No evaluation has been performed to show the adequacy and efficacy of the
cleaning and disinfection process used in parenteral filling room [redacted] as
specified by SOP 14-014-08 [21 CFR 211.42(c)(10)(v)].

5. Investigations of a batch failure or any of its components processed in the
aseptic processing area did not extend to other drug products that may have
been associated with a specific failure or discrepancy. The heat exchanger used
in the Small Volume Parenteral manufacturing rooms [redacted] and [redacted]
was found to be contaminating the water for injection (WFI) with bacteria. The
failure investigation did not extend to reviewing the possible impact on other
previously manufactured drug products. In addition, the heat exchanger
continued to be used to manufacture other parenteral products after the
equipment was identified as being contaminated. Furthermore, the filter
integrity test procedure outlined in SOP 14-177-01 does not specify a limit on
the number of times a filter can be flushed or rewetted. [21 CFR 211.192 and 21
CFR 211.42(c)(10)(vi)]

6. All established procedures for production and process control for
manufacturing of pharmaceuticals are not followed and documented at the time of
performance. For example, during the filling procedures for Factrel®, Lot
431334, the [redacted] air sampler was not placed in the location designated by
SOP 14-017-21. In the Package and Product Integrity Examination established in
SOP 14-059-10 specifies that each vial will be visually examined to assure the
integrity of the filled and sealed products. During the establishment
inspection, one of the analysts assigned to perform the visual inspection was
observed to look away from the line on several occasions thus allowing other
vials to pass the inspection site. [21 CFR 211.100(b)]

It is our assessment that the deviations listed above and discussed with your
firm’s senior management are significant and are a reflection of weaknesses
in one or more of the systems designed to control the manufacture of veterinary
pharmaceuticals purported to be sterile.

The cGMP deviations noted during the December 2003 establishment inspection,
where the firm’s employees failed to follow Standard Operating Procedures, do
not appear to be isolated events. On November 12, 1999, your firm recalled a
lot of Synovex Plus (Trenbolone Acetate and Estradiol Acetate) because it was
released for distribution despite failing content uniformity testing. On or
about April 30, 2002, Fort Dodge Animal Health sent a letter to FDA’s Center
for Veterinary Medicine's (CVM), Division of Compliance requesting the rework
of one lot of Synovex H (Testosterone Propionate, Estradiol Benzoate) because
the release assay showed that the product potency was approximately 10% below
the labeled claims.

It should also be noted that similar rework requests were made for products
manufactured at the Fort Dodge Laboratories, Riverside Drive location. On or
about April 15, 2002, Fort Dodge Animal Health sent a letter to CVM’s
Division of Compliance requesting rework of one lot of Torbutrol Tablets
(Butorphanol Tartrate) because the tablets failed average weight testing. The
firm had made a similar request during November 1999 to rework a previous lot
of Torbutrol Tablets for a similar failure. On or about May 2, 2002, Fort Dodge
Animal Health sent a letter to CVM’s Division of Compliance requesting rework
of one lot of EtoGesic Tablets (Etodolac) due to tablet chipping and cracking.
The firm made a similar request for three other lots of EtoGesic Tablets on or
about May 30, 2001.

The commonality regarding the above referenced reworks is that the firm’s
requests stated that personnel training and experience were factors in the
product quality as well as failure to follow Standard Operating Procedures.

We reviewed your firm's’s response to the FDA-483 observations dated January
14, 2004 and signed by Michael Mlodzik, Associate Director, Pharmaceutical
Regulatory Affairs. We acknowledge that your firm has made some changes and
provided additional training to your Quality Assurance Auditing Staff as well
as to the employees that work in the sterile core in response to FDA’s
inspectional observations. Your firm has revised twenty-two SOPS associated
with the sterile core operation, personnel aseptic conduct, environmental
monitoring, microbial testing for the water for injection (WFI) system, filter
integrity testing, packaging, and product integrity visual examination. Several
of the aforementioned SOPS are viewed as critical to achieve cGMP compliance
for an aseptic pharmaceutical manufacturing facility. The proposed corrections
will be verified during the next establishment inspection.

The above identification of violations is not intended to be an all-inclusive
list of deficiencies at your facility. It is your responsibility to assure
adherence with each requirement of the Act and its implementing regulations.
Deviations from the cGMP regulations were noted on a FDA Form 483 that was
issued to and discussed with Dr. Vickie L. Hall, M.S., Ph.D., Vice President of
the Iowa Operations and other members of the staff at the Fort Dodge location
during a close-out meeting held on the final day of the inspection. A copy of
the FDA Form 483 is enclosed for your information.

You should know that these violations might result in FDA taking regulatory
action without further notice to you. These actions include, but are not
limited to, seizure and/or injunction. Also, other federal agencies are
informed about certain Warning Letters issued by FDA so they may consider this
information when awarding government contracts.

Please inform this office, in writing, within fifteen (15) working days of
receiving this letter of the steps you are taking to correct these deviations.
If the corrective actions are going to extend past fifteen days, please include
in your response a detailed and specific timeline for the completion of your
actions. In addition, please contact the District Office to schedule a meeting
regarding your response to this letter. The written response should be
delivered at the meeting. At this meeting, it is anticipated that discussion
will be held regarding corrective actions taken by your firm, the effectiveness
of these actions, and the status of sterile drug products manufactured under
the conditions found during the inspection.

You should direct your reply to Ralph J. Gray, Compliance Officer, at the above
address.


Sincerely,
________
See my cats: http://community.webshots.com/album/56955940rWhxAe
Raw Diet Info: http://www.holisticat.com/drjletter.html
http://www.geocities.com/rawfeeders/ForCatsOnly.html
Declawing Info: http://www.wholecat.com/articles/claws.htm
  #8  
Old June 29th 04, 05:22 PM
Karen
external usenet poster
 
Posts: n/a
Default

So in english what does this mean?


"Osiris Virus" wrote in message
om...

http://www.ncbi.nlm.nih.gov/entrez/q..._uids=14621215

***

J Am Vet Med Assoc. 2003 Nov 1;223(9):1283-92.


Multicenter case-control study of risk factors associated with
development of vaccine-associated sarcomas in cats.

Kass PH, Spangler WL, Hendrick MJ, McGill LD, Esplin DG, Lester S,
Slater M, Meyer EK, Boucher F, Peters EM, Gobar GG, Htoo T, Decile K.

Department of Population Health and Reproduction, School of Veterinary
Medicine, University of California, Davis, CA 95616, USA.

OBJECTIVE: To determine whether particular vaccine brands, other
injectable medications, customary vaccination practices, or various
host factors were associated with the formation of vaccine-associated
sarcomas in cats. DESIGN: Prospective multicenter case-control study.
ANIMALS: Cats in the United States and Canada with soft tissue
sarcomas or basal cell tumors. PROCEDU Veterinarians submitting
biopsy specimens from cats with a confirmed diagnosis of soft tissue
sarcoma or basal cell tumor were contacted for patient medical
history. Time window statistical analyses were used in conjunction
with various assumptions about case definitions. RESULTS: No single
vaccine brand or manufacturer within antigen class was found to be
associated with sarcoma formation. Factors related to vaccine
administration were also not associated with sarcoma development, with
the possible exception of vaccine temperature prior to injection. Two
injectable medications (long-acting penicillin and methyl prednisolone
acetate) were administered to case cats more frequently than to
control cats. CONCLUSIONS AND CLINICAL RELEVANCE: Findings do not
support the hypotheses that specific brands or types of vaccine within
antigen class, vaccine practices such as reuse of syringes,
concomitant viral infection, history of trauma, or residence either
increase or decrease the risk of vaccine-associated sarcoma formation
in cats. There was evidence to suggest that certain long-acting
injectable medications may also be associated with sarcoma formation.

Publication Types:
Multicenter Study

PMID: 14621215 [PubMed - indexed for MEDLINE]



  #9  
Old June 29th 04, 05:22 PM
Karen
external usenet poster
 
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So in english what does this mean?


"Osiris Virus" wrote in message
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http://www.ncbi.nlm.nih.gov/entrez/q..._uids=14621215

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J Am Vet Med Assoc. 2003 Nov 1;223(9):1283-92.


Multicenter case-control study of risk factors associated with
development of vaccine-associated sarcomas in cats.

Kass PH, Spangler WL, Hendrick MJ, McGill LD, Esplin DG, Lester S,
Slater M, Meyer EK, Boucher F, Peters EM, Gobar GG, Htoo T, Decile K.

Department of Population Health and Reproduction, School of Veterinary
Medicine, University of California, Davis, CA 95616, USA.

OBJECTIVE: To determine whether particular vaccine brands, other
injectable medications, customary vaccination practices, or various
host factors were associated with the formation of vaccine-associated
sarcomas in cats. DESIGN: Prospective multicenter case-control study.
ANIMALS: Cats in the United States and Canada with soft tissue
sarcomas or basal cell tumors. PROCEDU Veterinarians submitting
biopsy specimens from cats with a confirmed diagnosis of soft tissue
sarcoma or basal cell tumor were contacted for patient medical
history. Time window statistical analyses were used in conjunction
with various assumptions about case definitions. RESULTS: No single
vaccine brand or manufacturer within antigen class was found to be
associated with sarcoma formation. Factors related to vaccine
administration were also not associated with sarcoma development, with
the possible exception of vaccine temperature prior to injection. Two
injectable medications (long-acting penicillin and methyl prednisolone
acetate) were administered to case cats more frequently than to
control cats. CONCLUSIONS AND CLINICAL RELEVANCE: Findings do not
support the hypotheses that specific brands or types of vaccine within
antigen class, vaccine practices such as reuse of syringes,
concomitant viral infection, history of trauma, or residence either
increase or decrease the risk of vaccine-associated sarcoma formation
in cats. There was evidence to suggest that certain long-acting
injectable medications may also be associated with sarcoma formation.

Publication Types:
Multicenter Study

PMID: 14621215 [PubMed - indexed for MEDLINE]



 




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