FDA WARNING_LETTER - Innovative Medical Manufacturing Co - August 12, 2010

On August 8-12, 2010, an FDA inspection of Innovative Medical Manufacturing Co. in Chunan, Taiwan, revealed that the firm's medical devices, including the EZ Stabilizer, EZ connect, Infiltration Tubing, Hypodermic needle set, and Dental irrigation tubing set, are adulterated. This is due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Specifically, the firm failed to establish and maintain adequate design validation procedures as required by 21 CFR 820.30(g). Examples cited include the Hypodermic needle set and Dental irrigation sets' Design History Files (DHFs), which lacked documentation of initial production unit evaluations under defined operating conditions to ensure conformity to user needs and intended uses, despite design verification activities. The firm's DHFs stated that formal clinical trials or design validation tasks were not needed due to common market use or equivalence to predicate devices.

The FDA requires prompt corrective action. Failure to comply may result in device detention without physical examination upon U.S. entry, advisement to U.S. federal agencies regarding contract awards, denial of premarket approval applications for Class III devices, and refusal of Certificates to Foreign Governments. A follow-up re-inspection will be scheduled. The firm must respond in writing within fifteen working days, detailing corrective actions, prevention plans, and