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

During an inspection conducted from February 13-17, 2023, the FDA issued a Form 483 to Gadal Laboratories Inc., an OTC drug manufacturer in Miami, Florida. The observations highlight significant deficiencies across multiple quality systems, indicating a lack of adherence to current Good Manufacturing Practices (cGMP). Key violations include pervasive failures within the Quality Unit. The Quality Control Unit did not consistently review and approve critical documents such as process validations and analytical method validations. Laboratory operations exhibited serious data integrity concerns, including shared instrument passwords, unmanaged raw data sheets with correction fluid use, and incorrect instrument timings. Furthermore, the company failed to establish appropriate specifications and adequately test incoming raw materials, relying on unvalidated supplier data. Production equipment lacked complete qualification (Performance Qualification), and cleaning procedures were unvalidated, with visible contamination noted in a "clean" tank. Investigations into discrepancies, such as unperformed testing by a terminated analyst and out-of-specification product results, were either inadequate or not documented. The Quality Unit also failed to implement and track essential quality processes like change controls, CAPAs, and risk assessments. Procedural non-compliance extended to warehousing, with product released without Quality Control approval, and inadequate control over labeling materials and their approval in batch records. Gadal Laboratories Inc. is required to thoroughly address these observations to ensure the quality, safety, and efficacy of its manufactured drug products.