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...]
PHARMACEUTICAL COMPANY JELFA SA (POLAND) RECEIVES WARNING LETTER (7/14/11)
JELFA SA DISTRIBUTES FINAL PRODUCT WITH QUESTIONABLE STERILITY 1.  Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed [21 C.F.R. § 211.192]. For example, The inspection documented that (b)(4) … [Read more...]
