The U.S. Food and Drug Administration flagged various lapses, including failure to establish required laboratory control mechanisms, at Glenmark Pharmaceuticals Ltd.'s Goa-based manufacturing plant.
The regulator inspected the company's Bardez-based facility in Goa, which produces drug formulations, from May. 12 to May. 20. It noted "significant violations of Current Good Manufacturing Practice regulations for finished pharmaceuticals".
In the warning letter, the FDA pointed out the company's failure "to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications".
"Your investigations into rejected batches failed to extend to other batches, dosage strengths, and drug products for tablet compression machine settings," it noted.
The U.S. FDA also said the plant administration failed to establish and follow required laboratory control mechanisms.
The regulator pointed out that the company failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug produced.
It asked the Mumbai-based drug maker to come up with a remedial plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drugs.
The warning letter issued by U.S. FDA usually identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use.
The letter also makes clear that the company must correct the problem and provides directions and a timeframe for its plans for correction.
The U.S. FDA then checks to ensure that the company's corrections are adequate.
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