FDA EIR - Darmerica, LLC - March 11, 2022

The FDA conducted an inspection of Darmerica, LLC, a repacker and relabeler of active pharmaceutical ingredients (APIs), from March 7-11, 2022. This compliance follow-up, guided by Compliance Program 7356.002F and ICH Q7A, assessed the firm's adherence to Good Manufacturing Practices (21 CFR 210/211). The inspection resulted in a Form FDA 483, citing several observations. Main issues included a deficient system for evaluating critical suppliers, with incomplete vendor survey forms and quality agreements that did not mandate analytical methods on Certificates of Analysis (COAs). The firm also failed to perform periodic COA verification and lacked comprehensive impurity testing in stability data. Controls for the FTIR Spectrometer were found inadequate, exhibiting shared passwords, absence of user roles, and insufficient training evaluations. Additionally, annual product reviews lacked trending of analytical data, and cleaning procedures in critical areas were observed to be insufficient. Darmerica’s management acknowledged the observations and committed to implementing corrections, promising a written response within fifteen business days. This inspection builds on a previous 2019 inspection where prior deficiencies were verified as corrected.