Category Archives: Regulatory Compliance

ZHEJIANG JIUZHOU PHARMACEUTICAL CO. RECEIVES IMPORT ALERT (3/18/14)

FDA PROVIDES NO RATIONALE FOR ALERT After the Warning Letter for Zhejiang Jiuzhou Pharmaceutical Co. was published in a recent Blog (8/20/14), several of my colleagues sent me comments regarding this Chinese Active Pharmaceutical Ingredient (API) source. They were particularly … Continue reading

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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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