FDA EIR - Fermic S.A. de C.V. - December 13, 2024

A comprehensive cGMP surveillance inspection of Fermic S.A. de C.V., an Active Pharmaceutical Ingredient (API) manufacturer, was conducted by the FDA from December 9-13, 2024. The inspection was carried out under compliance programs for API and animal drug manufacturing, focusing on the company's Quality, Materials, Facilities and Equipment, Production, Laboratory, and Packaging and Labeling systems. The current inspection concluded with a "No Action Indicated" (NAI) classification, signifying that no objectionable conditions requiring an FDA Form 483 were identified. However, several discussion items were raised with the firm, including an incorrect root cause identified for a deviation, a complex Product Quality Review, and limited data provided for customer complaints.

This inspection followed a previous assessment in March 2020, which had resulted in a "Voluntary Action Indicated" (VAI) classification due to issues such as inadequate investigations, a pre-signed document, and insufficient water testing data. Discussion points from that prior inspection also included concerns about method verifications and laboratory audit trail reviews. All items from the previous FDA-483 were confirmed to have been corrected during the current review. Management cooperated fully, and no samples were collected during the inspection.