FDA Halts Imports from Troubled India Drugmaker

The FDA barred beleaguered drugmaker Ipca Laboratories from shipping drugs to the U.S because of good manufacturing practice violations — the 27th time the agency has cracked down on GMP violations at Indian drug facilities in the last two years.

The FDA issued the import alert to Ipca, halting all shipments of antibiotics and other finished drugs produced at its Ratlam, India, manufacturing plant. The alert, the first to an Indian pharma company in 2015 for violating GMPs, did not elaborate on the specific deviations that prompted the action.

Ipca’s Ratlam facility has experienced quality problems before. Last July, the company temporarily halted shipments of active pharmaceutical ingredients made at Ratlam in response to an inspection that found data integrity violations, an area that is receiving heightened scrutiny by FDA investigators.

The drugmaker’s Pithampur, India, facility received a separate Form 483 in October. The six-observation form also contained data integrity violations, including deleting and overwriting raw data files.

Ipca could not be reached for comment.

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