A Food and Drug Administration inspection at an Apotex Inc. manufacturing facility revealed “significant violations” of current good manufacturing practice (cGMP) regulations, according to a warning letter the agency released April 13.
FDA said the violations at the facility in Toronto, which were found during inspections in July and August 2009, are similar to violations the agency described in a previous warning letter regarding an Apotex plant in Etobicoke, Ontario, near Toronto (7 PLIR 837, 7/17/09).
“These identical cGMP violations demonstrated a lack of adequate process controls and raised serious questions regarding” quality and production systems at Apotex, ...
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