483
All Pharma, LLCAll Pharma, LLC – FDA 483, Nov 15, 2019
Record Details
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.
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ID · 574b3884-a273-4854-8e55-d2c5678cdc34
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