FDA 483 - UQUIFA Mexico, S.A. de C.V. - July 23, 2018

An FDA inspection of Uquifa Mexico S.A. de C.V. in Jiutepec, Morelos, Mexico, revealed significant deficiencies in their manufacturing practices. The firm was cited for inadequate laboratory controls, specifically regarding the investigation and resolution of out-of-specification results, and for insufficient control over water used in API operations. Additional observations included incomplete procedures for material handling and a lack of fully established process parameters in cleaning validation, indicating a need for improved quality systems.