FDA 483 - Llorens Pharmaceuticals International Division, Inc. - March 11, 2020

Llorens Pharmaceuticals International Division, Inc. in Miami, FL, was cited for significant deficiencies in its quality control unit, laboratory facilities, and record-keeping practices during an FDA inspection. The firm failed to establish and follow written procedures for critical analytical processes like HPLC chromatogram evaluation and stability testing, and did not adequately investigate out-of-specification results. Additionally, unsanitary laboratory glassware and incomplete batch production records for in-process controls were observed, indicating a lack of robust quality systems for manufacturing OTC drugs and dietary supplements.