FDA 483 - UQUIFA Mexico, S.A. de C.V. - July 27, 2018

During an inspection from July 23-27, 2018, the FDA identified significant deficiencies at Uquifa Mexico S.A. de C.V., an Active Pharmaceutical Ingredient (API) manufacturer. The observations highlighted non-compliance with current Good Manufacturing Practices (cGMP). A key issue involved laboratory controls, where procedures for Out-of-Specification (OOS) results permitted retesting and averaging without a scientific basis for invalidating initial findings or fully investigating root causes. For example, investigations into particle size OOS results concluded issues like "air bubbles" or "improper sonication" without sufficient documented evidence or robust corrective actions. Similarly, microbial OOS results lacked proper investigation. Further observations included inadequate control over water used in API operations, evidenced by incomplete testing for drinking water standards and improperly sealed water holding tanks. Material control procedures were also found lacking, with uncontrolled blank API labels stored without proper documentation. Finally, cleaning validation and procedures for shared manufacturing equipment lacked precise parameters and relied excessively on operator judgment, compromising consistent and effective cleaning. Uquifa Mexico is expected to promptly address these observations by conducting thorough investigations, implementing robust corrective and preventive actions, and ensuring full compliance with cGMP regulations.