FDA WARNING_LETTER - RMO, Inc. - August 26, 2011

On August 22-26, 2011, the FDA inspected RMO, Inc. in Denver, CO, a manufacturer of Class II orthodontic plastic brackets and a repackager/relabeler of Class II dental adhesives, headgear, resins, and impression material. The inspection found that the devices are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Significant deviations include: 1. Failure to validate the injection molding process for Miura Plastic Brackets and their packaging/labeling process (21 CFR 820.75(a)). This was a repeat observation from a January-February 2009 inspection. 2. Failure to establish and maintain corrective and preventive action (CAPA) procedures, specifically verifying or validating CAPA effectiveness (21 CFR 820.100(a)(4)). Reviewed Engineering Service Requests (ESRs) lacked effectiveness verification, and Material Review Board (MRB) actions lacked documentation of implemented corrective actions. 3. Failure to establish and maintain procedures for acceptance activities, including in-process inspection documentation for Miura Plastic Brackets and incoming acceptance procedures for partially pre-labeled poly bags (21 CFR 820.8