Author Archives: Barry A. Friedman, PhD LLC

About Barry A. Friedman, PhD LLC

Regulatory Compliance, Expert Witness, Pharmaceuticals, Biotechnology, Aseptic Processing, GMP, GLP, Quality Control, Positron Emission Tomography (PET), Microbiology, Process Validation, Validation of Analytical and Microbiological Methods

SMITHKLINE BEECHAM, LTD, CORK IRELAND RECEIVES WARNING LETTER FROM FDA (03/18/14)

FIRM FAILS TO SUFFICIENTLY INVESTIGATE PHARMACEUTICAL WASTE CONTAMINATION EVENT During an FDA investigation of SKB in Cork, Ireland, the FDA encountered an unusual situation where the pharmaceutical waste tank was found to have contaminated various other tankage used to manufacture APIs. Part … Continue reading

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FDA’S CDER LISTING OF TOP EIGHTEEN OBSERVATIONS FOR 2013

TOP FOUR OBSERVATIONS INCREASE SIGNIFICANTLY OVER 2012 Each fiscal year the FDA issues the various FDA 483 Observations from the various Centers to include CBER, CDER, CDRH, etc.  This Blog focuses only upon those issued by Center for Drug Evaluation … Continue reading

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

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 … Continue reading

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BAXTER INITIATES U.S. VOLUNTARY RECALL OF ONE LOT OF PERITONEAL DIALYSIS SOLUTION (3/05/14)

CONTAINER-CLOSURE NON-INTEGRITY APPEARS TO PERMIT MOLD GROWTH  COMMENT Baxter International Inc initiated a recall for a single lot of DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose.  While the recall is due to non-integrity of the container-closure, it appears that … Continue reading

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ISSUE WITH STERILITY CONTROLS WITHIN MANUFACTURING LEADS TO RECALL (1/16/14)

ISSUE OCCURS WITHIN VIETNAM PRODUCTION FACILITY The Mentholatum Co. recently issued a Recall for several different eye drops that were manufactured in Vietnam.  Similar eye drops manufactured in Japan were not included within this Recall.  The Recall was initiated due … Continue reading

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FDA PROHIBITS INDIAN FACILITY FROM PRODUCING AND DISTRIBUTING DRUGS FOR U.S. MARKET

ANOTHER RANBAXY FACILITY IS ADDED TO EXISTING CONSENT DECREE The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical   ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug … Continue reading

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FDA ANNOUNCES VOLUNTARY NATIONWIDE RECALL OF ALL NON-EXPIRED STERILE DRUGS FROM ABRAMS ROYAL COMPOUNDING PHARMACY (12/21/13)

MICROBIAL ADVERSE EVENT CAUSES RECALL The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas. The … Continue reading

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JUBILANT HOLLISTERSTIER, LLC RECEIVES WARNING LETTER (11/27/13)

FIRM FAILS TO ASSURE ADEQUATE USE OF SPORICIDAL AGENTS AND CLEANING SUPPLIES Jubilant HollisterStier, Spokane, WA was audited by the FDA between April 15 and May 10, 2013.  The FDA reviewed the firm’s response from May 30 and noted that … Continue reading

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JUBILANT HOLLISTERSTIER, LLC RECEIVES WARNING LETTER (11/27/13)

FIRM FAILS TO PERFORM MEDIA FILL PROCESS SIMULATIONS FOLLOWING MAJOR RENOVATION Jubilant HollisterStier, Spokane, WA was audited by the FDA between April 15 and May 10, 2013.  The FDA reviewed the firm’s response from May 30 and noted that sufficient … Continue reading

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Wockhardt’s Walui and Chikalthana Facilities, Maharasthtra Receive Warning Letter (11/25/13)

Data Manipulation Continues to be a Major Issue  After a somewhat quiet month, CDER is again active in India.  Their current concern is with a Company that should be familiar to each of us.  And the issues in many cases … Continue reading

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