FDA WARNING_LETTER - IOPI Northwest Company, LLC - February 22, 2008

During a February 2008 inspection, the FDA determined that the firm's Iowa Oral Performance Instrument (IOPI) is a medical device. The inspection revealed the device is adulterated because manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. Failure to establish and maintain procedures for corrective and preventive action (CAPA) (21 CFR 820.100(a)). The firm has never initiated CAPA or established procedures. 2. Failure to establish procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)). No complaint handling procedures exist despite manufacturing the IOPI. 3. Failure to establish and maintain procedures to ensure device history records (DHRs) are maintained to demonstrate manufacturing in accordance with the device master record (21 CFR 820.184). DHRs do not include acceptance activities, testing performed, or fully documented procedures with review and approval of finished devices. 4. Failure to establish procedures for quality audits and conduct such audits to ensure quality system compliance and effectiveness (21 CFR 820.22). No procedures or audits have been conducted.

The FDA requires prompt corrective action. Failure to comply may result in seizure,