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Barry A. Friedman, PhD LLC

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

FIRM RECALLS SUNSCREEN LOTIONS FOLLOWING RETESTING

September 27, 2013 By Barry Friedman Leave a Comment

MICROORGANISMS INCLUDE GRAM NEGATIVE BACTERIA, YEAST AND MOLDS On Monday, September 23, 2013 W.S. Badger Co. announced a voluntary recall of all lots of its 4-ounce Baby SPF 30 Sunscreen Lotion and one lot of its 4-ounce SPF Kids Sunscreen Lotion because of microbial contamination.  The recall is being conducted with the knowledge of the U.S. food and Drug … [Read more...]

TOP 15 BACTERIA REPRESENT 50% OF BACTERIAL ISOLATES IDENTIFIED

June 22, 2011 By Barry Friedman Leave a Comment

ACCUGENIX IDENTIFIED WHAT MICROORGANISMS REPRESENT THE OTHER 50% While having knowledge of the most frequently identified bacteria is informative, it is important to note that these Top 15 bacteria identified from manufacturing environments, as cited in the original post, only represent approximately 50% of the microbes that are identified during routine monitoring and … [Read more...]

BACTERIA MOST OFTEN SUBMITTED FOR IDENTIFICATION TESTING DURING 2010

May 17, 2011 By Barry Friedman Leave a Comment

FREQUENTLY ENCOUNTERED BACTERIAL ENVIRONMENTAL ISOLATES Microbiological consulting professionals  are often requested to assist Clients with the identification of various environmental microorganisms to include bacteria that are isolated from their various HVAC and Utility Systems during facility commissioning and on-going operations.  These … [Read more...]

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FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2014

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