Mission Hills, S.A. de C.V. – FDA 483, May 25, 2018

Mission Hills, S.A. de C.V., an OTC drug manufacturer in San Jose Iturbide, Guanajuato, Mexico, was cited for significant deficiencies across multiple systems during an FDA inspection. Observations included inadequate equipment cleaning and maintenance, lack of dual verification for component additions, deficient laboratory controls for water sampling, and severely delayed complaint investigations. Additionally, the firm failed to extend investigations of batch discrepancies to other potentially affected batches.