FDA recently commented on the report entitled “FDA’s Contribution to the Drug Shortage Crisis” for the Honorable Elijah E. Cummings. Within this letter from Jeanne Ireland, Assistant Commissioner for Legislation, she lays out the FDA’s response to specific questions that Mr. Cummings asks about Drug Shortages and whether the FDA contributed to them. His letter includes: “The … [Read more...]
FDA WORKS WITH VARIOUS VENDORS DURING SANOFI PASTEUR’S INABILITY TO PRODUCE THERACYS BCG DUE TO BIOLOGICAL PRODUCT SHORTAGE
COMMENT The FDA is often criticized because it is viewed as creating biological and drug product shortages when it issues a FDA 483, Warning Letter, Consent Decree or executes a seizure. This Alert published by the FDA demonstrates several of the actions that the FDA may initiate to minimize these shortages. In addition, the FDA now typically adds a "boilerplate" paragraph … [Read more...]
FDA (CBER) ISSUES ELEVEN PAGE 483 TO SANOFI PASTEUR (04/25/11)
COMMENT CBER issued to Sanofi Pasteur an eleven page, 32 Observation Form FDA 483 following an audit of their Toronto, Canada facilities. The dates of inspection encompassed the time frame of April 10 - 25, 2012. CBER previously published the Warning Letter regarding this subject which was initially noted within this Blog earlier in the week. The most significant … [Read more...]
FDA (CBER) ISSUES MULTI-NATIONAL WARNING LETTER TO SANOFI PASTEUR (07/12/12)
COMMENT The FDA published last Wednesday (July 25, 2012) a multipage Warning Letter to Sanofi Pasteur’s facilities in Toronto, Canada and Marcy l’Etoile, France. This Warning letter followed extensive GMP audits of both facilities between March 19 – April 2, 2012 (France) and April 10 and April 25, 2012 (Canada). Within the Warning Letter are issues relating to the … [Read more...]
USP MICROBIAL REQUIREMENTS LACKING FOR MONOGRAPHS FOR PURIFIED WATER AND WATER FOR INJECTION
COMMENT Often during webinars and seminars, the question is raised regarding the specifications for Purified Water (PW) and Water for Injection (WFI). The USP has responded with an explanation as part of their series on Microbiological Frequently Asked Questions (FAQ). Please read below to learn more about how one should develop … [Read more...]
