FDA blocks Teva from selling vet drugs and warns Apotex
pharmafile | August 6, 2009 | News story | Manufacturing and Production | Apotex, FDA, Teva
The FDA’s clampdown on quality standards continues apace, with Teva’s animal health unit in Missouri and an Apotex plant in Canada the latest in the firing line.
The FDA has effectively shuttered the Teva facility in St Jospeh, saying that an inspection revealed “significant” failures in Good Manufacturing Practice (GMP), including the release into the marketplace of medicine shipments that had failed quality control checks.
Transgressions documented between 2007 and 2009 included release of contaminated and adulterated products, failure to maintain equipment properly and lack of an effective quality control unit, according to documents posted on the FDA website.
The unit sells a broad range of veterinary medicines, both branded under the DVM name and generic, and is said to be the largest generic veterinary drug supplier operating in the US. However, the unit brings in only a small percentage of Teva’s overall sales, estimated at around $130 million last year out of total group sales of over $11 billion.
“Teva Animal Health cannot resume manufacturing and distributing veterinary drugs until adequate methods, facilities, and controls are established and an independent expert inspects the facilities and procedures and certifies that they comply with GMP,” said the agency in a statement.
Meanwhile, generic drugmaker Apotex – the largest Canadian owned pharmaceutical company – is also under the scrutiny of both the FDA and Health Canada. The firm received a ‘483 warning letter’ for GMP violations in the manufacture of solid dose products at its facility in Etobicoke, Ontario.
Deficiencies encountered during the FDA inspection in late 2008 included a failure to investigate whether a batch that failed specifications had been distributed, and a high level of batch failures that indicates “a lack of adequate process controls”, according to the warning letter. Two rejected batches of the antiviral acyclovir may have been shipped to the US, it said.
The latest FDA actions follow seizures of medicines and a shutdown of a plant operated by Caraco, a subsidiary of India’s Sun Pharmaceutical Industries, and an ongoing investigation by the agency into potential quality control violations at Mylan, another generic drug manufacturer.
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