FDA 483 - Bestco LLC - August 01, 2025

The FDA issued a Form 483 to an unnamed pharmaceutical firm following an inspection conducted from July 28 to August 1, 2025. The observations highlight significant deviations from current Good Manufacturing Practices (cGMP), primarily concerning laboratory control systems and facility/equipment integrity, posing risks to drug product quality and safety. Regarding laboratory controls, the inspection revealed that an unvalidated Excel spreadsheet is used for critical assay calculations for raw materials, finished over-the-counter (OTC) drug products, and stability testing. This spreadsheet lacks essential access controls and a change history, failing to ensure data accuracy, reliability, and integrity. Furthermore, several critical issues were identified within the facility and equipment systems, specifically in the OTC tablet manufacturing area. Equipment surfaces in direct contact with unwrapped drug products exhibited deficiencies such as black oily residue, dents, surface damage, and cracked or missing protective covers. A section of a conveyor belt was entirely uncovered, exposing drug product to environmental contaminants. Chipped and flaking paint on processing equipment and a damaged cushioning pad further exposed drug products to potential contamination from degraded materials and foreign particulates. These conditions indicate a lack of adequate controls to prevent alteration of drug product safety, identity, strength, quality, or purity. The firm is expected to address these serious observations to ensure compliance with regulatory standards.