 2nd Half of FDA Warning Letter to Fort Dodge
This is the 2nd half of the FDA Warning Letter to Fort Dodge from above. Post was too long for one post.
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,
Charles W. Sedgwick
District Director
Kansas City District |