FDA 483 - Oakwood Laboratories LLC - August 13, 2024

An FDA inspection of Oakwood Laboratories LLC in Solon, OH, revealed significant deficiencies across multiple areas of their drug product manufacturing operations. The firm failed to adequately investigate consumer complaints, often concluding root causes as "unknown" without corrective actions. Furthermore, severe issues were noted in laboratory controls, including lack of quality oversight, data integrity concerns, and inadequate computer system validation and user privileges. Finally, the inspection found poor maintenance and labeling practices for equipment and materials within the facility.