FDA 483 - Signa S.A. de C.V. - April 15, 2022

Signa S.A. de C.V., an API manufacturer in Toluca De Lerdo, Mexico, was cited for significant deficiencies in its quality control unit and manufacturing processes. The inspection revealed inadequate controls over computerized systems, failures to follow written procedures for investigations and deviations, and incomplete cleaning validation studies. These issues indicate a lack of robust quality oversight and potential risks to data integrity and product quality.