FDA EIR - Darmerica, LLC - July 18, 2019

An FDA inspection of Darmerica, LLC, an active pharmaceutical ingredient (API) repacker and relabeler in Casselberry, FL, was conducted from July 15 to July 18, 2019. The inspection adhered to Compliance Program 7356.002F and ICH Q7, focusing on Good Manufacturing Practices for APIs, referencing 21 CFR 210/211. Despite being classified as NAI (No Action Indicated) overall, the inspection identified six significant violations detailed in a Form FDA 483 issued to Mr. Syveon D. Liu, the Quality Assurance Manager. Key issues included a failure to investigate out-of-specification (OOS) temperature excursions for API storage equipment, and the acceptance of supplier certificates of analysis without conducting identity testing for incoming APIs. The quality unit also failed to consistently review and release critical components and closures for production. Additionally, equipment used for API storage had not been qualified, the temperature monitoring system was not validated, and the firm lacked a validated shipping process for temperature-sensitive APIs. Finally, required annual product reviews had not been completed. Mr. Liu acknowledged these observations and committed to submitting a written response within 15 business days, with the FDA reiterating the importance of compliance to prevent potential enforcement actions.