FDA 483 - Eksa Mills S.A. de C.V. - April 19, 2022

Eksa Mills S.A. de C.V., an OTC drug manufacturer in Heroica Puebla De Zaragoza, Mexico, was inspected by the FDA. The inspection revealed significant deficiencies, primarily the complete absence of a quality control unit. This led to widespread issues including a lack of written procedures, inadequate record-keeping, no stability program, insufficient component testing, and poor equipment cleaning protocols for drug products shipped to the U.S. market.