India's Wockhardt and Granules India each reported surviving a U.S. FDA inspection without any problems being cited. Such inspections generally take months before any definitive compliance decisions are made, however.
The Wockhardt inspection was of its plant at Chikalthana that 14 months ago was banned from exporting drugs to the United States because of failures in good manufacturing practices. The latest inspection was conducted to check on steps the drugmaker had taken to fix the problems.
Granules India said its Gagillapur plant was also inspected by the U.S. agency and that no GMP errors were found. That inspection was triggered when the company filed for approval of one of its generic drugs. The plant makes intermediate formulations and finished dosages, the company said.
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