shenberg dental, – FDA Warning Letter, Mar 16, 2011

On August 11, 2011, the FDA issued a Warning Letter to Shenberg Dental, dba Therozone, following an inspection from February 24 to March 16, 2011. The inspection revealed that their TherOzone T-1000 and T-8000 devices are 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 include: 1. Failure to establish and maintain design control procedures, specifically for design validation (21 CFR 820.30(g)). 2. Failure to establish and maintain procedures for controlling purchased products and services, including lack of agreements with suppliers for change notification (21 CFR 820.50). 3. Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)). 4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)). 5. Failure to establish and maintain document control procedures (21 CFR 820.40). 6. Failure to establish procedures for quality audits