Piezosurgery Inc. – FDA Warning Letter, Apr 12, 2010

On March 25-April 12, 2010, an FDA inspection of Piezosurgery, Inc., an initial importer, distributor, and servicing unit for electrical surgical dental devices, revealed adulterated and misbranded devices. The firm's methods, facilities, or controls for manufacturing, packing, storage, or installation did not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. **Failure to maintain complete complaint files and procedures (21 CFR § 820.198(a)):** Insufficient information was documented from complainants to evaluate validity, and the "P001 Complaint Reception" procedure did not ensure adequate information for initial review. 2. **Failure to fully investigate complaints (21 CFR § 820.198(c)):** Devices failing outside the warranty period were not returned to the manufacturer for investigation, despite error codes being recorded. 3. **Failure to establish complaint handling procedures for MDR evaluation (21 CFR § 820.198(a)(3)):** The "P001 Complaint Reception" procedure lacked details on information needed to determine if an event was reportable under 21 CFR Part 803 as a malfunction Medical Device Report (MDR). 4. **Failure to document