FDA RECOMMENDS ALERT TO AVOID DRUG SHORTAGES In a previous Blog (May 24, 2012) the issue of Warning Letters and how the FDA now on a routine basis is asking their Clients to advise them if the Warning Letter and its consequences will result in shortages was discussed. In this Blog, the FDA is using “Risk Management†… [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...]
FDA CBER STERILITY TESTING REQUIREMENTS (610.12) AMENDED (06/04/12)
ELIMINATES SPECIFIED STERILITY TEST METHODS, CULTURE MEDIA FORMULAE, AND CULTURE MEDIA TEST REQUIREMENTS -- CLARITY OR CONFUSION? Summary (Effective June 4, 2012) The Food and Drug Administration (FDA) is amending the sterility test requirements for biological products. This rule provides manufacturers of biological products greater flexibility, as appropriate, and encourages … [Read more...]
Burkholderia cepacia: This Decision Is Overdue
FDA Believes Now is the Time to Remove the Bug from Pharmaceutical Manufacturing The FDA recently published an article wherein they discuss the rationale for removing B. cepacia from the pharmaceutical arena. They cite a number of reasons why they believe that this bacterium and its variants should no longer be permitted. These discussions are … [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...]
