Irregularities Found at 10 Firms That Make Generic Drugs

The Food and Drug Administration’s inspections of a dozen generic drug makers found a range of manufacturing and record keeping irregularities at all but two of the companies, an FDA official told Congress today.

Paul Vogel, deputy director of the FDA’s generic drug compliance staff, outlined for the House Energy and Commerce investigations subcommittee problems that had been found during FDA special inspections ordered in the wake of disclosures of fraud and corruption within the industry and at the FDA.

Vogel said the FDA found no significant problems at two manufacturers that were targeted as part of the inspections: Able Laboratories and Zenith Labs, neither a major manufacturer of generic drugs.

Deficiencies were found at American Therapeutics Inc., Barre-National, Bolar Pharmaceuticals, Par Pharmaceuticals, Pharmaceutical Basics Inc., Pharmafair, Quad Pharmaceuticals, Superpharm Corp., Vitarine Pharmaceuticals and Watson Laboratories.