FDA 483 - Cyan Labs S.A. de C.V. - May 16, 2025

An FDA inspection of Cyan Labs, S.A. de C.V. in Ciudad Apodaca, Mexico, a manufacturer of OTC drug products, revealed significant deficiencies across its quality system. Observations included inadequate investigations, poor equipment and facility maintenance, insufficient component testing, lack of supplier qualification, unvalidated production processes, and inadequate computer system controls. These issues indicate a broad failure to ensure the quality, purity, and strength of their drug products.