Auro Peptides Limited – FDA 483, Aug 21, 2026

Auro Peptides Limited in Kandi Mandal, India, an API manufacturer, was cited for significant facility and equipment deficiencies during an FDA inspection. Observations included uncleaned critical raw material storage, equipment discoloration, water damage in a recall room, and compromised flooring in a cold room storing API intermediates. These issues indicate poor control over manufacturing environments and potential product contamination risks.