Eksa Mills S.A. de C.V. – FDA Warning Letter, Apr 19, 2022

The FDA inspected Eksa Mills S.A. de C.V. in Puebla, Mexico, from April 18-19, 2022, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated. The firm's April 24, 2022, response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Equipment Cleaning and Maintenance (21 CFR 211.67(a)):** The firm failed to adequately clean and maintain equipment. They manufactured OTC drug products and commercial chemical solutions on the same equipment, posing a cross-contamination risk. No written cleaning procedures or equipment use logs for tanks were maintained. The FDA requires discontinuing drug manufacturing on shared equipment or providing a plan for dedicated equipment and conducting a risk assessment for all previously manufactured drugs on shared equipment, including potential recalls. 2. **Quality Control Unit Responsibilities (21 CFR 211.22):** The Quality Unit (QU) failed to ensure CGMP compliance and product specifications. Deficiencies included inadequate procedures for QU roles (vendor qualification, batch release, reserve samples, investigations, complaints, training), insufficient testing of incoming components, lack of a stability program, and inadequate batch record maintenance. The FDA requires a comprehensive assessment and remediation plan for the QU, ensuring its authority and resources, robust procedures, oversight, final batch review