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 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...]
REGULATORY COMPLIANCE/EXPERT MICROBIOLOGICAL WITNESS CONSULTATION
Regulatory Compliance -- Form FDA 483/Warning Letters With the advent of only 15 calendar days to respond to regulators following a Form FDA 483 or Warning Letter, it is incumbent upon the recipients of these to use the time most productively to minimize any further regulatory actions. Understanding the Observation becomes the initial step. Unless the individuals are … [Read more...]
NEW ADDITION TO WARNING LETTERS’ “BOILERPLATE” PARAGRAPHS
CDER RESPONDS TO MANAGEMENT OF LACK OF AVAILABILITY OF FINISHED DRUG PRODUCT OR API Recently the FDA has added a new standardized paragraph to each of its Warning Letters for both Finished Drug Products and for Active Pharmaceutical Ingredients. Please review how the FDA desires you to respond. "If, as a result of receiving this Warning Letter or in general, you … [Read more...]
NUSIL TECHNOLOGY LLC RECEIVES FDA WARNING LETTER (032312)
API MFG CITED FOR OOS AND MICROBIOLOGICAL ISSUES (B. cepacia) -- REFERENCES RECENT PDA J. PHARM SCI & TECH 1. Your firm failed to have an adequate out-of-specification (OOS) procedure to conduct thorough and scientifically sound investigations including corrective actions. For example, the OOS report number (b)(4) for lot (b)(4) of Simethicone Emulsion USP … [Read more...]
