Laboratorios Jaloma S.A. de C.V. – FDA Warning Letter, Dec 19, 2025

Laboratorios Jaloma S.A. de C.V. received an FDA warning letter following an inspection of its Guadalajara, Mexico facility from December 15 to 19, 2025. The inspection identified significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering the company"s over-the-counter drug products adulterated under the Federal Food, Drug, and Cosmetic Act. The main issues involved a critical breakdown in data integrity and laboratory controls. Notably, facility staff admitted to documenting samples that were never actually taken and failing to follow required incubation periods for microbial testing. Additionally, the company used unvalidated testing methods that did not meet standard safety requirements and lacked necessary controls over computerized systems. Specifically, gas chromatography equipment lacked audit trails and data backups, making it impossible to ensure the accuracy of electronic records. These findings demonstrate that the Quality Control Unit failed to provide adequate oversight of manufacturing and testing processes. Due to these failures, the FDA has placed the company on an import alert, prohibiting its products from entering the United States. To address these violations, Laboratorios Jaloma must hire an independent consultant to conduct a comprehensive audit. The company is required to perform a retrospective risk assessment of its products, investigate the root causes of data inaccuracies, and implement a global strategy for corrective actions. A detailed response must be submitted to the FDA within 15 working days outlining the steps taken to ensure future compliance and data reliability.