Thorn Ford Dental Laboratory LLC – FDA Warning Letter, Feb 25, 2015

On February 5-25, 2015, an FDA inspection of Thorn Ford Dental Laboratory LLC in Bothell, Washington, revealed that their TAP® 3 TL, Elite TL, and Silent Partner anti-snoring/obstructive sleep apnea devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's March 5, 2015, response to the FDA 483 was deemed inadequate.

Key violations included: 1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: No procedures were available, and the submitted policies lacked appropriate statistical methodology, verification/validation processes, analysis of diverse quality data sources, and provisions for management review. 2. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: No procedures were available, and submitted documents did not formally designate a complaint unit or clarify complaint applicability. 3. **Failure to establish and maintain purchasing controls (21 CFR 820.50)**: No documentation for supplier evaluation/selection or agreements for supplier notification of changes. The firm had taken no action on this. 4. **Failure to establish and maintain finished