Lynn Peavey Co – FDA Warning Letter, Sep 21, 2010

On September 15-21, 2010, an FDA inspection of Lynn Peavey Company in Lenexa, KS, revealed that their Sexual Assault Evidence Collection Kit and Blood Alcohol Collection Kit, classified as devices, were 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).

Key violations included: 1. **Failure to establish and maintain adequate Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a))**: The CAPA procedure lacked requirements for analyzing quality data, investigating nonconformities, identifying corrective actions, verifying actions, implementing changes, disseminating information, and submitting for management review. 2. **Failure to evaluate and select suppliers based on quality requirements (21 CFR 820.50(a)(1))**: No supplier evaluations existed for the Sexual Assault Evidence Collection Kit and Blood Alcohol Collection Kit. 3. **Failure to establish and maintain procedures for incoming product acceptance (21 CFR 820.80(b))**: No incoming inspection, test, or verification procedures or criteria existed for components like (b)(4) in the Sexual Assault Kit or safety-capped needles in the Blood Alcohol Kit. 4. **Failure