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

During an FDA inspection conducted from May 12 to May 16, 2025, Saenz, Apodaca, a manufacturer of over-the-counter (OTC) drug products, received a Form FDA 483 detailing significant deviations from current Good Manufacturing Practices (cGMP). The observations highlighted several critical areas requiring attention. The company failed to thoroughly investigate unexplained discrepancies, such as out-of-limit readings from its monitoring system, whether or not the batch was distributed. Facility and equipment maintenance were found inadequate, with observations including cracking on a production tank, uncleaned scales exhibiting residues and deterioration, and unidentified staining on the ceiling of the non-dedicated dispensing area. Furthermore, the firm failed to adequately test incoming components for purity, strength, and quality, specifically neglecting microbial contamination testing and insufficient sampling of pharmaceutical ingredients. Saenz, Apodaca also accepted supplier certificates of analysis without validating their reliability. Production and process controls were deficient, lacking validated processes for multiple OTC products and failing to maintain complete production records, such as original weight data from dispensing tags. Lastly, computer system controls were inadequate, as a laboratory analyst could delete files on the HPLC equipment used for assay testing. Saenz, Apodaca must implement comprehensive corrective and preventive actions to address these cGMP deficiencies to ensure product quality and regulatory compliance.