FDA 483 - R&D Engineering, Inc. of Earlham - December 15, 2022

R&D Engineering, Inc. of Earlham, a manufacturer of Class 2 medical devices, was cited for two significant observations during an FDA inspection. The firm failed to establish written procedures for device history records, leading to incomplete documentation for its 800cc Suction Canisters. Additionally, obsolete work instructions were found in use at the point of operation, indicating deficiencies in their document control system.