FDA WARNING_LETTER - E.A. Beck & Co. - August 25, 2010

This FDA Warning Letter, dated December 14, 2010, was issued to E. A. Beck & Co. following an August 10-25, 2010 inspection. The firm's Erich Arch Bar and Mathieu for Wire and Elastic Style Ligature Ties devices were found adulterated and misbranded. Adulteration under 21 U.S.C. 351(h) resulted from numerous Quality System (QS) regulation (21 CFR Part 820) violations, including failures in corrective and preventive actions, purchasing, process validation, complaint handling, acceptance activities, software validation, Device Master Records, Device History Records, and labeling control. The devices are also misbranded under 21 U.S.C. 352(t)(2) for lacking written Medical Device Reporting (MDR) procedures (21 CFR Part 803). The Erich Arch Bars and wires are adulterated under 21 U.S.C. 351(f)(1)(B) for not having an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). Further misbranding violations include failure to submit a 510(k) premarket notification (21 U.S.C. 352(o)), inadequate labeling directions (21 U.S.C. 352(f)(1)), and non-compliance with establishment registration and device listing requirements (21 U.S.C. 352(o)). The FDA requires prompt corrective actions within 15 working days, with a detailed response including documentation and a timetable. Non-compliance could lead to regulatory actions like seizure, injunction, civil penalties, and impact federal contracts, PMA approvals, and Certificates to Foreign Governments.