FDA cites two for GMP lapses

Having momentarily finished with Caraco in Michigan, FDA inspectors made their way south to Teva Animal Health in St. Joseph, MO, and then north to Apotex in Toronto.

Inspectors found adulterated veterinary drugs and numerous violations of Good Manufacturing Practices, including failures to reject out-of-spec drugs, to maintain equipment, and to establish a quality control unit. The company is now prevented from manufacturing and distributing its products until it achieves GMP compliance and gets a signoff from the regulator, according to an FDA announcement.

The FDA action stem from inspections conducted between June 2007 and last June. A Teva spokesperson said the company regretted the deficiencies and has started corrective measures, including product analyses, employee retraining, and equipment and process re-validation.

In Toronto, Apotex received a Form 483 for "significant" GMP deviations in the manufacture of non-sterile oral solid dosage drug products. Failure to submit information to regulators concerning contamination, deterioration or spec deviations was also cited, according to Secure Pharma Chain blog.

These latest inspections follow drug seizures and plant shutdowns for generics-maker Caraco in late June, leading to lawsuits in July. Late July brought a 67% profit drop at parent company Sun Pharmaceutical Industries of India, due to "lower sales of finished drugs and regulatory problems in the U.S.," according to the Wall Street Journal.

- here's the FDA release on Teva
- see the Apotex article
- here's the Wall Street Journal report