FDA WARNING_LETTER - Preservation Solutions, Inc. - May 19, 2017

On August 21, 2017, the FDA issued a Warning Letter to Preservation Solutions, Inc. following an inspection from April 21 to May 19, 2017. The inspection revealed that the firm's organ transplant preservation solutions, classified as devices, were adulterated because their manufacturing, packing, storage, or installation methods did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to adequately validate processes (21 CFR 820.75(a))**: Deficiencies were found in media fills, stability studies (accelerated aging and real-time), equipment qualification (lack of EDQ/PQ, incomplete IQ records), and cleanroom validation (failure to meet acceptance limits, unvalidated cleaning methods). The firm's response was inadequate, lacking updated procedures and systemic corrective actions. 2. **Failure to adequately establish complaint handling procedures (21 CFR 820.198(a))**: Four complaints received since January 2017 were not properly documented, entered into the corrective action system, or reviewed by QA, despite reporting defects. The firm's response was inadequate, as it did not address a retrospective review of other complaints. 3. **Failure to adequately establish environmental control procedures (21 CFR 820.70(c))**: Cleanrooms were