The FDA issued a warning letter to over-the-counter drugmaker Essnd Global for serious GMP deficiencies at its facility in Maharashtra, India.
The agency rapped the company for releasing a finished drug product without fully testing it for the identity and strength testing of its active ingredient.
The facility also failed to fully test incoming components for identity, purity and strength, and allowed its suppliers to send raw materials, labeling and packaging materials without certificates of analyses (COAs), agency investigators found.
“Identity testing is required for each component lot used in drug product manufacturing, and you can only rely on a COA for other component attributes by validating the supplier’s test results at appropriate intervals,” the agency said.
The facility also lacked written procedures for stability studies, deviation investigations, out-of-specification investigations and product release.