FDA WARNING_LETTER - Peace Medical Inc. - April 05, 2011

An FDA inspection of Peace Medical, Inc. in Orange, New Jersey, from March 29 to April 5, 2011, revealed that the firm's Demistifier Isolation Chamber and Ambulance Transport Isolation System devices are adulterated and misbranded. The inspection identified significant violations of the Quality System (QS) regulation (21 CFR Part 820), including failures to establish design control procedures (820.30(a)), adequately implement corrective and preventive action procedures (820.100), and maintain device master records (DMRs) (820.181) and device history records (DHRs) (820.184).

Additionally, the devices are misbranded due to the firm's failure to establish an internal system for timely Medical Device Reporting (MDR) as required by 21 CFR 803.17(a). Further adulteration was noted because the firm lacks approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) applications (Section 501(f)(1)(B) of the Act). The devices are also misbranded due to the absence of a 510(k) premarket notification (Section 510(k) of the Act) and failure to fulfill annual establishment registration and device listing requirements for fiscal year 2011 (Section 502(o) and 510 of the Act).

Peace Medical, Inc. must take prompt corrective actions and notify the FDA in writing within fifteen business days, providing documentation and a timetable for completion. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on government contracts, PMA approvals, and Certificates to Foreign Governments.