FDA 483 - Gadal Laboratories Inc. - February 17, 2023

Gadal Laboratories Inc, an OTC drug manufacturer in Miami, Florida, was inspected by the FDA from February 13-17, 2023. The inspection revealed numerous significant deficiencies across its production, laboratory, facilities and equipment, materials, quality, and packaging and labeling systems. Key issues included inadequate quality unit oversight, poor data integrity practices, insufficient equipment qualification, and a lack of robust investigation and change control procedures, indicating a systemic failure to adhere to Good Manufacturing Practices.