FDA WARNING_LETTER - Mavidon Medical Products - May 23, 2008

An FDA inspection of Mavidon Medical Products from May 21-23, 2008, revealed that the firm's Class II Mavidon Medical Electrode Jelly devices are adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation, 21 CFR Part 820. The inspection identified eight significant violations. These include the failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d)), leading to the release of products without required viscosity and conductivity testing. The firm also failed to ensure each lot met acceptance criteria prior to release (21 CFR 820.80(d)(1)), establish incoming product acceptance procedures (21 CFR 820.80(b)), and implement adequate training procedures for personnel (21 CFR 820.25(b)). Further deficiencies involved the lack of documentation for finished device acceptance activities (21 CFR 820.80(e)), unsuitable building design and space (21 CFR 820.70(f)) with operations and raw materials observed outside, and the failure to validate computer software used for manufacturing and inventory control (21 CFR 820.70(i)). Lastly, Device Master Records were incomplete regarding packaging and labeling specifications (21 CFR 820.181(d)). The firm's June 24, 2008, response to the FDA 483 observations was deemed largely inadequate. Mavidon must promptly correct these violations within 15 working days, providing detailed corrective actions, prevention plans, and timelines, or face potential regulatory actions such as seizure, injunction, or civil money penalties, and impact on federal contracts.