FDA EIR - OXYGEN DEVELOPMENT, L.L.C. - January 17, 2018

An FDA inspection of Oxygen Development, LLC, a contract manufacturer of cosmetics, sunscreens, and topical OTC human drug products, was conducted from December 27, 2017, to January 17, 2018. This comprehensive inspection, performed under the regulatory framework for Drug Manufacturing Inspections (CP 7356.002), aimed to assess the firm's adherence to Current Good Manufacturing Practice (cGMP) regulations and follow up on previous issues.The inspection uncovered several significant deviations, formally documented in an FDA Form 483 and further discussed verbally. Main violations included critical failures within the quality system, such as releasing drug products without adequate laboratory testing for active ingredient identity and strength, insufficient investigation of out-of-specification results and other discrepancies, and non-compliance with the established stability testing program. Deficiencies also extended to manufacturing process controls, with a lack of validation for key processes, inadequate cleaning and sanitization protocols for equipment, and incomplete batch production records. Additionally, employee training in cGMP and specific job functions was found to be insufficient for temporary staff, and issues with raw material container integrity and the security of labels were identified.Oxygen Development, LLC management was notified of these findings and reminded of their obligation to ensure full compliance. The company was instructed to provide a written response to the Florida District Office within 15 business days. Failure to implement effective corrective actions could lead to further regulatory enforcement measures.