FDA WARNING_LETTER - Conair Corporation - May 31, 2013

The FDA issued a Warning Letter to Conair Corporation following an inspection from May 21-31, 2013, which found that their manufactured heating pads are adulterated and misbranded. The devices are adulterated under Section 501(h) of the Act because their manufacturing, packing, storage, or installation methods do not conform to the Quality System (QS) regulation (21 CFR Part 820). Specific QS violations include failure to establish and maintain procedures for: receiving, reviewing, and evaluating complaints to determine MDR reportability (21 CFR 820.198(a)(3)); controlling device design to ensure requirements are met (21 CFR 820.30(a)); and implementing corrective and preventive action (21 CFR 820.100(a)). The firm's heating pads are also misbranded under Section 502(t)(2) for failing to furnish required material or information under Section 519 of the Act and 21 CFR Part 803 (Medical Device Reporting). Misbranding violations include failure to submit MDR reports for serious injuries (21 CFR 803.50(a)(1)) and device malfunctions (21 CFR 803.50(a)(2)) within 30 days, and failure to develop, maintain, and implement written MDR procedures (21 CFR 803.17). Conair must take prompt action to correct these violations and respond in writing within fifteen business days, detailing corrective actions, prevention plans, and a timetable. Failure to comply may result in regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts, premarket approvals, and Certificates to Foreign Governments. A follow-up inspection will be required.