FDA Warns Another Foreign API Maker for Data Integrity Issues

Indian active pharmaceutical ingredient maker Mahendra Chemicals was hit with an FDA warning letter for cGMP deviations including data integrity issues — the latest in a crackdown on foreign API makers.

During the May 19 to May 24, 2014, inspection, FDA investigators observed employees completing batch production record entries days after the operations had ended, releasing lots without proper approval and making notes on loose paper to record original, critical data, then destroying the notes after transcribing them.

The Ahmedabad, Gujarat, India, firm also failed to secure access to data. Inadequate controls of the computerized analytical systems raise questions about the authenticity of data and the quality of the firm’s APIs, the July 13 letter says.

Employees also lacked on-the-job training. The firm’s training program requires a report for each session that includes names of the trainer and trainee, subjects covered and evaluation sheets, but Mahendra was unable to provide any reports to investigators.

The FDA asked Mahendra to provide a comprehensive evaluation of the extent of inaccuracies in its reported data, a risk assessment of potential effects of drug product quality and a management strategy, including details of its CAPA plans. The agency recommended hiring an outside cGMP consultant.

The FDA recently handed another Indian API maker — Nosch Labs — a Form 483 for data issues. Similar issues have triggered warning letters for API makers in the Czech Republic, Thailand and China.

Mahendra Chemicals did not respond to a request for comment by press time. View the warning letter at www.fdanews.com/07-29-15-MahendraChemicals.pdf. — Kellen Owings