FDA issues warning letters to Indian OTC drugmaker for falsified logbooks and to two others for GMP testing lapses

The U.S. Food and Drug Administration sent a warning letter to an over‑the‑counter drugmaker in India after discovering that the company had submitted falsified logbooks to the agency.

In addition, the FDA warned two other OTC manufacturers for multiple good manufacturing practice violations, highlighting deficiencies in their testing procedures.

These actions illustrate the agency’s heightened scrutiny of compliance in the OTC sector and signal that firms must maintain rigorous documentation and testing standards to avoid regulatory penalties.

Manufacturers facing such warnings may need to implement corrective measures and could see increased oversight, which may impact product availability and market confidence.