FDA 483 - Laboratorios Jaloma S.A. de C.V. - December 19, 2025

Laboratorios Jaloma S.A. de C.V., an OTC drug manufacturer in Guadalajara, Mexico, was cited for significant deficiencies in laboratory controls and data integrity during an FDA inspection. Observations included incomplete and unreliable laboratory records, unvalidated and improperly executed testing procedures, deficient Out of Specification investigations, and unvalidated computer systems used for critical testing. These issues indicate a systemic lack of control over quality assurance processes.