FDA WARNING_LETTER - Freeman Manufacturing Company Corporation - September 04, 2009

The FDA issued a Warning Letter to Freeman Manufacturing Company Corporation following an inspection from September 2-4, 2009, in Sturgis, Michigan. The firm manufactures VENA-FLO? Medical Compression Stockings, VENA-FLO? ANTI-EMBOLISM STOCKINGS, and VENA-FLO? Fashion 20 Medical Support Stockings, which are regulated as devices. The inspection revealed significant violations. The devices are adulterated under Section 501(f)(1)(B) of the Act because the firm lacks approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) applications. Additionally, the devices are misbranded under Section 502(o) for failure to submit a 510(k) premarket notification. A deficiency in the Quality System (QS) regulation, 21 CFR 820.22, was also noted, specifically the firm's failure to adequately establish and conduct quality audits, with no internal audits performed since July 2007 despite an annual requirement. The FDA requires prompt corrective action within 15 working days, including a detailed plan to prevent recurrence and a timetable for implementation. Failure to comply may lead to regulatory actions such as seizure, injunction, civil money penalties, impact on federal contracts, and denial of Certificates to Foreign Governments. The letter emphasizes the firm's responsibility to ensure overall compliance.