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 managing quality and failure to transfer all quality or … [Read more...]
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 manufacturing practice (CGMP) for the manufacture of active pharmaceutical … [Read more...]
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 my additional comments. “2012 INSPECTION: Health Canada's 2012 regular GMP inspection of the Sainte-Foy facility concentrated … [Read more...]
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, CDER, FDA recently presented at the ISPE meeting on June 4, 2014 where he discussed this topic and illustrated the … [Read more...]
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 did not release specifics of the involved issues, it did indicate some of the findings were similar to those … [Read more...]
