FDA 483 - Milla Pharmaceuticals, Inc. - March 12, 2026

Between March 9 and March 12, 2026, the Food and Drug Administration (FDA) conducted an inspection of Milla Pharmaceuticals, Inc., an Abbreviated New Drug Application (ANDA) sponsor located in White Bear Lake, Minnesota. The resulting Form 483 identified a significant deficiency regarding the company"s oversight of post-marketing adverse drug experience reporting. The primary violation involves a failure to establish and follow formal procedures for managing pharmacovigilance vendors. Specifically, the FDA investigator noted that while a vendor was contracted in November 2021 to handle safety reports, Milla Pharmaceuticals failed to perform an initial qualification of this partner. Furthermore, the firm neglected to conduct mandatory annual reassessments or the biennial audits required by their own contract. This lack of oversight suggests a breakdown in the company"s system for monitoring drug safety after products reach the market. These findings were issued under the regulatory authority of Section 704(b) of the Federal Food, Drug, and Cosmetic Act. While this document is not a final agency determination of compliance, the company is expected to respond. Milla Pharmaceuticals must either discuss any objections to these findings with the FDA or submit a comprehensive plan for corrective actions to address the vendor management and safety reporting gaps identified during the inspection.