Hemosphere, Inc. (A CryoLife, Inc. Company) – FDA Warning Letter, Oct 16, 2012

On September 17 - October 16, 2012, the FDA inspected Cryolife Inc., a medical device manufacturer, and found its devices adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulations (21 CFR Part 820).

Violations included: 1. **Process Validation (21 CFR 820.75(a)):** Disinfectant efficacy verification studies used unrepresentative coupons and failed to evaluate all critical surfaces. Cryolife's responses were deemed inadequate or required further review. 2. **Corrective and Preventive Actions (21 CFR 820.100(b)):** Environmental action trending reports omitted alerts and required graphs, and failed to include all actions/alerts for a critical room. Cryolife's responses were inadequate, lacking identified corrective actions to prevent recurrence. 3. **Environmental Controls (21 CFR 820.70(c)):** Critical classified areas lacked active environmental monitoring, personnel aseptic technique monitoring was only quarterly during simulations, and incoming municipal water with high bioburden was used for disinfectants. Cryolife's responses required additional information for evaluation. 4. **Complaint Handling (21 CFR 820.198(c)):** Multiple complaint investigations (e.g., patient