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

ZHEJIANG JIUZHOU PHARMACEUTICAL CO., LTD. (CHINA) RECEIVES WARNING LETTER (7/09/14)

APIs WERE MISBRANDED Zhejiang Jiuzhou Pharmaceutical Co., Ltd. (China) was inspected from October 21-24, 2013 at their active pharmaceutical ingredient manufacturing facility.  Deviations from CGMP were noted in the manufacture of the API. “Failure to implement an effective system of … Continue reading

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TRIFARMA S.p.A. (ITALY) RECEIVES WARNING LETTER (070714)

LETTER IS SIMILAR TO ONE RECEIVED BY CERIANO LAGHETTO PLANT (11/13) The FDA inspected the Trifarma S.p.A. pharmaceutical manufacturing facility, located at Via Pavese 2, Rozzano, Italy from January 27 – 29, 2014.  They identified significant deviations from current good … Continue reading

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HEALTH CANADA ISSUES SUMMARY REPORT FROM AUDIT OF ID BIOMEDICAL (GSK), SAINTE-FOY, QUEBEC

Health Canada recently issued a summary report of their recent audit of ID Biomedical (GSK).  Within this report, they presented summaries of both their 2012 and 2014 Inspections.  Enclosed are copies of selected sections of both Inspections as well as … Continue reading

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FDA Warning Letters – Their Relationship to Drug Shortages — An Interesting Counterpoint

Recently (June 12, 2014) I authored a Blog re: “FDA Warning Letters – Their Relationship to Drug Shortages”.  This Blog elicited several very interesting comments.  Within this Blog, I noted that Douglas C. Throckmorton, MD, Deputy Director for Regulatory Affairs, … Continue reading

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HEALTH CANADA ANNOUNCES GSK AUDIT OF STE. FOY, QUEBEC SITE

AUDIT RELEASE (7/3/14) FOLLOWS THAT OF FDA’S WARNING LETTER GSK (GlaxoSmithKline) recently received a Health Canada inspection report on July 3, 2014, almost a month (6/12/14) following FDA’s issuance of a Warning Letter for the same facility.  While Health Canada … Continue reading

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ID BIOMEDICAL CORP RECEIVES WARNING LETTER (6/12/14)

COMPANY CONTINUED TO FIND GRAM NEGATIVES IN PW WATER SYSTEM ID Biomedical Corp, a subsidiary of GSK Biologicals, located in Quebec, Canada was audited by the FDA from March 31 through April 9, 2014.  The FDA Investigators documented deviations from … Continue reading

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FDA Warning Letters – Their Relationship to Drug Shortages

The FDA has become keenly aware within the past several years of the impact that their audits have on the availability of drugs becoming available to the consuming public.  Douglas C. Throckmorton, MD, Deputy Director for Regulatory Affairs, CDER, FDA … Continue reading

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THE FDA AND TurboEIR – HOW IT’S MANAGED AND MISMANAGED FORM FDA 483s

TurboEIR is a FDA software program designed to standardize Form FDA 483s and Establishment Inspection Reports (EIR).  It was completely “rolled out” in October 2002. For each “Objectionable Condition” (FDA 483 Observation), TurboEIR requests the inspection team to choose a … Continue reading

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FDA FORM 483 FREQUENTLY ASKED QUESTIONS

OBTAIN THE ANSWERS TO THE QUESTIONS THAT EVERYONE ASKS This Blog site periodically provides 483s and Warning Letters as well as commentary as a service to its clientele. A question frequently asked is “when is a 483 issued as well … Continue reading

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FIND FDA WARNING LETTERS AND RECALLS THAT DISCUSS THE LATEST REGULATORY THOUGHTS

USE “KEY WORDS’ THAT PROVIDE FOCUSED SEARCHES Barry A Friedman, PhD has been publishing a variety of Regulatory Actions including information regarding Warning Letters, Recalls, and other regulatory activities for over three years. These 140+ Regulatory Actions often include FDA … Continue reading

Posted in 483, Consent Decree, Dietary Supplements, FDA Compliance, Import Alert, Import Ban, Microbiological Issues, New Guidances for Industry, Recall, Regulatory Compliance, Seizure, Warning Letters, Webinar | Tagged , , , , , | Leave a comment