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Barry A. Friedman, PhD LLC

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

CANTON LABORATORIES PVT. LTD, INDIA RECEIVES WARNING LETTER (2/27/14)

March 13, 2014 By Barry Friedman Leave a Comment

FIRM FALSIFIES MICROBIAL DATA Canton Laboratories, India was found to have reported analytical results without having performed the testing.  C of A’s stated that the data conformed to specifications; however, multiple personnel confirmed that the testing was not performed.  Similar data was observed in July 2008 with other testing.  Please read below to learn more about … [Read more...]

FDA FILES CONSENT DECREE OF PERMANENT INJUNCTION AGAINST MCNEIL-PPC AND TWO OF ITS OFFICERS

March 11, 2011 By Barry Friedman Leave a Comment

FDA NEWS RELEASE Comment The FDA issued a Consent Decree of Permanent Injunction bypassing a Warning Letter in their persuit of  J & J's failure to comply with CGMPs. For Immediate Release: March 10 2011 Media Inquiries: Shelly Burgess, 301-796-4651; shelly.burgess@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA, Justice Department take action against McNeil-PPC … [Read more...]

Permanent Injunction Deltex Pharmaceuticals January 18, 2011

January 29, 2011 By Barry Friedman Leave a Comment

Federal Government obtains permanent injunction against Deltex Pharmaceuticals Inc. Company charged with manufacturing and distributing drugs in violation of federal law The U.S. Food and Drug Administration today announced that the U.S. District Court for the Southern District of Texas entered a consent decree of permanent injunction against … [Read more...]

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