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Barry A. Friedman, PhD LLC

FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

FDA INCREASES VIGILANCE ON ASEPTIC PROCESSING FACILITIES

December 20, 2011 By Barry Friedman 4 Comments

 B/POR REVIEWS RISING TIDE OF FDA 483s AND WARNING LETTERS AT FIRMS TO INCLUDE BEN VENUE LABS, HOSPIRA AND FORMATECH  COMMENT  Policy changes and enforcement strategies implemented by the FDA have led to an increase in the number of inspection of sterile manufacturers -- especially injectables.  There is greater … [Read more...]

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