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...]
SMITHKLINE BEECHAM, LTD, CORK IRELAND RECEIVES WARNING LETTER FROM FDA (03/18/14)
FIRM FAILS TO SUFFICIENTLY INVESTIGATE PHARMACEUTICAL WASTE CONTAMINATION EVENT During an FDAÂ investigation of SKBÂ 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 of the rationale provided by SKB was that no reason existed … [Read more...]
PRELIMINARY REPORT OF NEW ENGLAND COMPOUNDING CENTER ISSUED BY MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH (DPH) (10/23/12)
NOTES FAILURE TO COMPLY WITH USP <797> AND STATE LAWS AND REGULATIONS BACKGROUND “Pharmacy Compounding†involves modifying commercially available products to meet the requirements of an individual patient based upon a prescription from a licensed provider. Within the State of Massachusetts, a total of 25 pharmacies meet … [Read more...]
NEW ENGLAND COMPOUNDING CENTER (NECC) POTENTIALLY CONTAMINATED MEDICATION: FUNGAL MENINGITIS OUTBREAK
Out of an abundance of caution, FDA is taking the additional step of recommending that health care professionals and consumers not use any product that was produced by NECC at this time. [UPDATED 10/06/2012] On October 4, 2012, the CDC and FDA recommended that all health care professionals cease use and remove from their pharmaceutical inventory any product produced by the New … [Read more...]
