The US Food and Drug Administration (FDA) has issued Apotex with another warning letter about cGMP violations at two plants explaining the firm’s response to previous warnings “is inadequate and lacks sufficient corrective actions.”
The facilities, in Etobiocoke and Signet Drive in Toronto, Canada, have been subject to an import alert since September when the FDA deemed Apotex had failed to correct deficiencies noted during inspections at the respective sites in 2008 and 2009.
The agency said the new warning, published yesterday, was issued due to “serious and repeat violations from the 2008 and 2009 inspections and because your response, dated September 3… is inadequate and lacks sufficient corrective actions.”
The observations include that the firm used portions of contaminated active pharmaceutical ingredient (API) lots to manufacture cetirizine HCl and metformin HCL tablets that were subsequently released for distribution and shipped to the US.
Additionally, the FDA questioned Apotex’ practice of repackaging and assigning new batch numbers to drug products and ingredients, which it said: “lacks a scientific rationale and documentation.”
The regulatory agency gave Apotex the standard 15 days to respond and warned it that failure to put together an appropriate corrective plan will mean that it continues to deny product made at the two facilities entry to the US.
Apotex, which recalled a number of products made at the facilities from the US, Australian and New Zealand markets lates last year, has not yet issued a response to the latest FDA warning letter.