YorkieTalk.com Forums - Yorkshire Terrier Community - View Single Post - Proheart 6 -- USA Today Editorial

Kris Christine · 06-18-2008, 05:21 AM

(continuation of Fort Dodge letter above)

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,
/s/
Charles W. Sedgwick
District Director
_______________________________________________

Rabies Shot Killed my Poodle May 28, 2008 Channel 5 News WCVB Woman: Rabies Shot Killed My Poodle - Boston News Story - WCVB Boston

Duration of Immunity to Canine Vaccines: What We Know and Don't Know, Dr. Ronald Schultz Duration of Immunity

What Everyone Needs to Know about Canine Vaccines, Dr. Ronald Schultz What Everyone Needs to Know About Canine Vaccines

World Small Animal Veterinary Association 2007 Vaccine Guidelines - WSAVA - Scientific Advisory Committee Scroll down to Vaccine Guidelines 2007 (PDF)

The 2003 American Animal Hospital Association's Canine Vaccine Guidelines are accessible online at Special Report .

The 2006 American Animal Hospital Association's Canine Vaccine Guidelines are downloadable in PDF format at About AAHA .

Veterinarian, Dr. Robert Rogers,has an excellent presentation on veterinary vaccines at www.newvaccinationprotocols.com Coming Soon!

October 1, 2002 DVM Newsletter article entitled, AVMA, AAHA to Release Vaccine Positions, AVMA, AAHA to release vaccine positions - - DVM

July 1, 2003 DVM Newsletter article entitled, What Do We Tell Our Clients?, Developing thorough plan to educate staff on changing vaccine protocols essential for maintaining solid relationships with clients and ensuring quality care 'What do we tell our clients?' - Developing thorough plan to educate staff on changing vaccine protocols essential for maintaining solid relationships with clients and ensuring quality care - DVM

July 1, 2003, DVM Newsletter article, Developing Common Sense Strategies for Fiscal Responsibility: Using an interactive template to plan service protocol changes Developing common sense strategies for fiscal responsibility - Using an interactive template to plan service protocol changes - DVM

Animal Wellness Magazine Article Vol. 8 Issue 6, How Often Does he REALLY Need A Rabies Shot Animal Wellness Magazine - devoted to natural health in animals

The Rabies Challenge Animal Wise Radio Interview
Listen to Animal Wise (scroll down to The Rabies Challenge 12/9/07)

The Vaccine Challenge Animal Talk Naturally Online Radio Show » The Vaccine Challenge - Show #91

US Declared Canine-Rabies Free -- CDC Announces at Inaugural World Rabies Day Symposium CDC Press Release - September 7, 2007

Rabies Prevention -- United States, 1991 Recommendations of the Immunization Practices Advisory Committee (ACIP), Center for Disease Control's Morbidity and Mortality Weekly March 22, 1991 / 40(RR03);1-19 Rabies Prevention -- United States, 1991 Recommendations of the Immunization Practices Advisory Committee (ACIP) "A fully vaccinated dog or cat is unlikely to become infected with rabies, although rare cases have been reported (48). In a nationwide study of rabies among dogs and cats in 1988, only one dog and two cats that were vaccinated contracted rabies (49). All three of these animals had received only single doses of vaccine; no documented vaccine failures occurred among dogs or cats that had received two vaccinations. "

06-18-2008, 05:21 AM	#4
Kris Christine YT Addict Join Date: Jan 2008 Location: THE RABIES CHALLENGE FUND Posts: 434	(continuation of Fort Dodge letter above) 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, /s/ Charles W. Sedgwick District Director _______________________________________________ Rabies Shot Killed my Poodle May 28, 2008 Channel 5 News WCVB Woman: Rabies Shot Killed My Poodle - Boston News Story - WCVB Boston Duration of Immunity to Canine Vaccines: What We Know and Don't Know, Dr. Ronald Schultz Duration of Immunity What Everyone Needs to Know about Canine Vaccines, Dr. Ronald Schultz What Everyone Needs to Know About Canine Vaccines World Small Animal Veterinary Association 2007 Vaccine Guidelines - WSAVA - Scientific Advisory Committee Scroll down to Vaccine Guidelines 2007 (PDF) The 2003 American Animal Hospital Association's Canine Vaccine Guidelines are accessible online at Special Report . The 2006 American Animal Hospital Association's Canine Vaccine Guidelines are downloadable in PDF format at About AAHA . Veterinarian, Dr. Robert Rogers,has an excellent presentation on veterinary vaccines at www.newvaccinationprotocols.com Coming Soon! October 1, 2002 DVM Newsletter article entitled, AVMA, AAHA to Release Vaccine Positions, AVMA, AAHA to release vaccine positions - - DVM July 1, 2003 DVM Newsletter article entitled, What Do We Tell Our Clients?, Developing thorough plan to educate staff on changing vaccine protocols essential for maintaining solid relationships with clients and ensuring quality care 'What do we tell our clients?' - Developing thorough plan to educate staff on changing vaccine protocols essential for maintaining solid relationships with clients and ensuring quality care - DVM July 1, 2003, DVM Newsletter article, Developing Common Sense Strategies for Fiscal Responsibility: Using an interactive template to plan service protocol changes Developing common sense strategies for fiscal responsibility - Using an interactive template to plan service protocol changes - DVM Animal Wellness Magazine Article Vol. 8 Issue 6, How Often Does he REALLY Need A Rabies Shot Animal Wellness Magazine - devoted to natural health in animals The Rabies Challenge Animal Wise Radio Interview Listen to Animal Wise (scroll down to The Rabies Challenge 12/9/07) The Vaccine Challenge Animal Talk Naturally Online Radio Show » The Vaccine Challenge - Show #91 US Declared Canine-Rabies Free -- CDC Announces at Inaugural World Rabies Day Symposium CDC Press Release - September 7, 2007 Rabies Prevention -- United States, 1991 Recommendations of the Immunization Practices Advisory Committee (ACIP), Center for Disease Control's Morbidity and Mortality Weekly March 22, 1991 / 40(RR03);1-19 Rabies Prevention -- United States, 1991 Recommendations of the Immunization Practices Advisory Committee (ACIP) "A fully vaccinated dog or cat is unlikely to become infected with rabies, although rare cases have been reported (48). In a nationwide study of rabies among dogs and cats in 1988, only one dog and two cats that were vaccinated contracted rabies (49). All three of these animals had received only single doses of vaccine; no documented vaccine failures occurred among dogs or cats that had received two vaccinations. "