FDA WARNING_LETTER - HMI Industries, Inc. - January 15, 2010

On December 1, 2009, through January 15, 2010, an FDA inspection of HMI Industries, Inc. in Strongsville, OH, identified that their "Defender" residential room air filtration system is a medical device. The inspection revealed the device is 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).

Violations include: 1. Failure to document corrective and preventive action (CAPA) activities, including investigations, corrective actions, and effectiveness verification (21 CFR § 820.100(b)). Examples cited are CAPA #1224 (motor noise) and #1226 (power circuit board issues), which lacked documentation of immediate actions, root cause, permanent actions, and effectiveness verification, and were canceled despite ongoing complaints. 2. Failure to implement complaint handling and failure investigation procedures, resulting in incomplete complaint files (21 CFR § 820.198(a)). Out of 29 complaints, many lacked documented CAPA requirements, root causes, corrective actions, and evaluation for Medical Device Reporting (MDR) to FDA. 3. Failure to develop production processes ensuring the "Defender" conforms to specifications (21