FDA WARNING_LETTER - Larson Medical Products, Inc. - March 21, 2008

During a March 14-21, 2008 inspection, the FDA found Larson Medical Products, Inc., a manufacturer of low-temperature thermoplastics for splinting and radiation therapy positioning devices, in violation of Current Good Manufacturing Practice (CGMP) requirements. The devices were deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with 21 CFR Part 820, the Quality System (QS) regulation.

Key violations included: 1. **Failure of management with executive responsibility** to ensure an adequate and effective quality system, lacking established procedures for corrective and preventive actions (CAPA), design control, medical device reporting (MDR), and acceptance activities. Management reviews of the QS were also undocumented. (21 CFR § 820.20) 2. **Failure to establish and conduct quality audits** to ensure QS compliance and effectiveness. (21 CFR § 820.22) 3. **Failure to establish and maintain CAPA procedures** and document CAPA activities, including analysis, investigation, verification, and validation of manufacturing changes. (21 CFR § 820.100) 4. **Failure to establish and maintain complaint handling procedures**, with undocumented complaints and evaluations. (21 CFR § 820.198) 5. **Failure to