FDA WARNING_LETTER - Gunnell, Inc. - June 30, 2010

An FDA inspection of Gunnell, Inc. in Millington, MI, from June 7-30, 2010, revealed significant violations concerning the manufacture of various wheelchair devices. The devices were found to be adulterated under 21 U.S.C. 351(f)(1)(B) due to the lack of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) application. They were also misbranded under 21 U.S.C. 352(o) for failing to submit a 510(k) premarket notification. Furthermore, the devices were 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).

Key QS violations included the failure to establish and maintain adequate procedures for complaint handling (21 CFR 820.198(a)), corrective and preventative actions (21 CFR 820.100(a)), purchasing controls (21 CFR 820.50), device history records (21 CFR 820.184), control of nonconforming product (21 CFR 820.90), equipment calibration (21 CFR 820.72), quality audits (21 CFR 820.22), document control (21 CFR 820.40), management review (21 CFR 820.20(c)), and employee training (21 CFR 820.25(b)). Additionally, the devices were misbranded under 21 U.S.C. 352(t)(2) due to the firm's failure to establish Medical Device Reporting (MDR) procedures (21 CFR 803.17).

Gunnell, Inc. must promptly correct these violations and respond to the FDA within fifteen working days, detailing corrective actions, prevention plans, and a timeline. Failure to comply may lead to regulatory actions such as seizure, injunction, civil money penalties, and impact contract awards or device approvals.