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...]
