FDA 483 - All Pharma, LLC - November 15, 2019

All Pharma, LLC, an OTC drug manufacturer and prescription drug relabeler in Hialeah, FL, received a Form 483 with significant observations. The inspection revealed critical failures in the quality control unit, including inadequate material release, insufficient investigation of out-of-specification results, and a deficient change control system. Additionally, issues with facility changes and unsuitable equipment surfaces were noted, indicating a broad lack of adherence to cGMP regulations.