FDA 483 - Darmerica, LLC - March 19, 2025

An FDA inspection conducted at Darmerica, LLC, an active pharmaceutical importer, repacker, and relabeler located in Davie, FL, from March 3-19, 2025, identified significant compliance deficiencies. The inspection report, issued to Mr. Syveon Lui, Director of Quality, detailed six observations. Key issues included the Quality Control Unit's failure to ensure materials were fully evaluated before release, leading to product distribution prior to complete third-party testing and Certificate of Analysis review. The firm also failed to verify the identity of incoming drugs, including biologics, before relabeling or repackaging, relying solely on manufacturer COAs without performing its own identity testing. Furthermore, Darmerica's Quality Control Unit did not adequately investigate critical deviations or quality-related complaints, failing to extend investigations to potentially affected lots or notify downstream customers of confirmed issues like product appearance discrepancies. Sampling procedures were found inadequate, as samples collected for contract lab testing were not confirmed to be representative of the batch, and supplier qualification processes were deficient, evidenced by a supplier providing inaccurate information leading to a recall and import alert. Finally, the firm lacked comprehensive written procedures for critical quality control activities, such as recall handling and laboratory testing, including documentation for test failures, indicating a systemic breakdown in its quality management system. Darmerica is required to address these serious deviations from good manufacturing practices.