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

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

Posted in FDA Compliance, Import Ban, Recall, Regulatory Compliance, Seizure | Tagged , , , , , , , | 1 Comment

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

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

Posted in FDA Compliance, Microbiological Issues, Permanent Injunction, Regulatory Compliance, Warning Letters | Tagged , , , , , , | Leave a comment