Third Apotex plant cited in FDA warning letter

Canada's Apotex has been sent a warning letter citing manufacturing violations at a facility in Toronto that are identical to those uncovered at another of its plants in 2008, says the FDA.

The letter indicates that US regulatory approval of new marketing applications at the generics manufacturer may be placed on hold, along with imports from the affected plant into the US, until the problems have been resolved.

Last year, the FDA placed all finished form drug products made at two Apotex' facilities in Ontario under an import alert, after an inspection uncovered good manufacturing practice (GMP) deficiencies.

In the latest letter, sent on 23 March, the FDA says an inspection of Apotex' facility in Toronto last summer found a number of problems at the plant, including contamination of drugs to treat diabetes (metformin) and allergies (cetirizine), leaking of dessicant material into primary packaging as well as cross-contamination likely to have resulted from inadequate cleaning of manufacturing equipment.

It also maintains that Apotex assigned new batch numbers and re-packaged products that had previously failed quality testing, including batches of oxcarbazepine for epilepsy and mood stabiliser lithium carbonate.

The letter cites "serious and repeat violations" at the plants and says that the company's response, sent to the agency in September 2009 is "inadequate and lacks sufficient corrective actions".

The FDA is also unhappy about the timeliness of Apotex' communication of problems reported by its customers. Under current field alerting reporting (FAR) rules this should be within three days of receipt, but in some cases Apotex did not notify the FDA until two months after it was made aware of a problem.

Apotex was given 14 days to respond in writing to the issues raised in the letter, which was dated 29 March.