FDA WARNING_LETTER - Chattem, Inc. - February 08, 2008

On February 5-8, 2008, an FDA inspection of Chattem, Inc., manufacturer of Icy Hot Heat Therapy Patches, revealed significant violations. The devices were deemed adulterated under 21 USC 351(h) due to non-conformance with Quality System (QS) regulation (21 CFR 820) and misbranded under 21 USC 352(t)(2) and 21 USC 352(f).

Key violations include: 1. **Corrective and Preventive Action (CAPA) Deficiencies (21 CFR 820.100(a)):** The CAPA SOP was inadequate, failing to address analysis of all quality data sources, statistical methodology, and verification of effectiveness. Chattem failed to initiate CAPAs for approximately 200 major complaints (burns, skin removal, irritation). While procedures were revised, documentation of personnel training on thorough investigations was lacking. 2. **Failure to Submit Medical Device Reports (MDRs) (21 CFR 803.50(a)(1)):** Chattem failed to submit 15 MDRs within 30 days for serious injuries. Although MDRs were eventually reported, documentation of adequate personnel training and successful implementation of MDR procedures was not provided. 3. **Failure to Report Corrections/Removals (21 CFR 80