FDA WARNING_LETTER - Premium Dental, LLC - August 05, 2009

On July 29, 2009, through August 5, 2009, the FDA inspected Premium Dental, LLC, initial distributor and importer of the Dr. Brux My Night Guard device. The inspection revealed the device is adulterated and misbranded.

Violations include: 1. **Adulteration (21 U.S.C. § 351(h))**: Failure to conform with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820). * **Failure to establish and maintain CAPA procedures (21 CFR § 820.100(a))**: Specifically, no procedures for analyzing quality data to identify nonconforming product causes. Responses were inadequate as the CAPA procedure (Revision A) does not specify verification/validation of effectiveness, and no training records were provided. * **Failure to establish and maintain complaint handling procedures (21 CFR § 820.198(a))**: No procedures or files to receive, document, process, and evaluate complaints, including determining if they require FDA reporting under 21 CFR § 803. Procedures appear adequate but implementation cannot be verified. * **Adulteration (21 U.S.C. 351(f)(1)(B))**: No approved Premarket Approval (