FDA EIR - Carolina Sports and Orthopedics Sales Inc - March 01, 2023

Carolina Sports and Orthopedics Sales Inc. in North Charleston, SC, underwent an initial FDA routine surveillance inspection from February 28 to March 1, 2023. The inspection, conducted under Compliance Program 7382.843 for Medical Device Manufacturers, evaluated the firm's quality system, focusing on corrective actions, purchasing controls, and production processes for cold pack therapy systems and other distributed Class I and II orthopedic devices. During the inspection, the company's owner acknowledged unawareness of the 21 CFR 820 medical device quality system requirements. The FDA-483, Inspectional Observation, cited five significant deficiencies. These included inadequate examination of device labeling, with products distributed lacking essential information like unique device identifiers or universal product codes. Furthermore, the firm failed to document evaluations of potential suppliers, lacked established procedures for acceptance activities of incoming devices, did not maintain complaint files, and had no established procedures for device servicing. Management "promised to correct" all observations documented on the FDA-483. The investigator also emphasized the necessity for implementing robust corrective and preventive action (CAPA) procedures and medical device reporting (MDR) procedures. The company was cautioned that continued non-compliance could lead to further enforcement actions, including Warning Letters, injunctions, or civil penalties.