FDA 483 - Valens Molecules Private Limited - September 13, 2024

Valens Molecules Private Limited Unit - II, an API manufacturer in Hyderabad, India, was cited for significant deficiencies in its laboratory controls. The inspection revealed a failure to perform required assay testing for drug substances and issues with the preparation and quality control of microbiological media. These findings indicate a lack of scientifically sound test procedures, posing potential risks to the identity, strength, quality, and purity of their drug substances.