FDA 483 - Organo Sintesis, S.A. De C.V.

An FDA inspection of Organo Sintesis, S.A. de C.V. in San Nicolas Tlazala, Mexico, revealed multiple significant deficiencies in their Active Pharmaceutical Ingredient (API) manufacturing operations. Key issues included inadequate quality control procedures, compromised data integrity in computerized systems, insufficient environmental controls, and incomplete employee training. These findings indicate a lack of robust quality management systems, posing a risk to the quality and purity of the APIs produced.