FDA issues warning letters to Indian OTC drugmaker over falsified logbooks and cites GMP lapses at two other firms

The FDA sent warning letters to an over‑the‑counter drug manufacturer in India after discovering the company had submitted falsified production logbooks.

The agency also cited two additional OTC manufacturers for multiple good manufacturing practice violations, including failures in testing procedures.

The FDA’s actions underscore heightened scrutiny of overseas suppliers and reinforce the need for rigorous compliance with GMP standards.