FDA 483 - Orange Lab Holdings - July 12, 2024

An FDA inspection conducted at Orange Lab Holdings from July 8-12 and July 18-19, 2024, revealed significant deviations from Current Good Manufacturing Practices (CGMP) for drug product manufacturing. Many of these observations were repeats from a prior 2023 inspection. The primary issues include a severely deficient Quality Control unit, lacking established written procedures for raw material specifications, non-conformance, deviations, out-of-specification (OOS) results, corrective/preventative actions, and document control. The company also failed to qualify third-party testing vendors and did not trend critical data such as complaints or process validations. Further concerns noted were the lack of validated cleaning procedures for equipment used in drug and cosmetic manufacturing, unvalidated manufacturing processes for OTC drug products, and inadequate controls over computer systems used for raw material inventory, which lacked validation and audit trails. Employees, including quality assurance and control personnel, had not received required CGMP training. The firm also failed to investigate OOS results from stability reports and made specification changes without proper change controls. Additionally, routine calibration and maintenance of equipment, including the water system, were not consistently performed or documented, and the stability program for OTC drug products lacked fixed acceptance criteria. Orange Lab Holdings must address these observations comprehensively to achieve compliance with CGMP regulations.