FDA WARNING_LETTER - Laser Dental Innovations - December 14, 2017

The FDA issued a Warning Letter to Laser Dental Innovations following a December 4-14, 2017 inspection, identifying their dental handpiece and laser fiber optic surgical devices as adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **CAPA Procedures (21 CFR 820.100(a)):** Failure to establish and document CAPA activities, including root cause analysis and effectiveness verification, as per their own SOP028A. The firm's response was inadequate, lacking specific changes to ensure compliance. 2. **Complaint Files (21 CFR 820.198(a)):** Failure to maintain complaint files and establish procedures for receiving and evaluating complaints. A CAPA was opened for multiple complaints, but no records were maintained. The response was inadequate, lacking retrospective evaluation of undocumented complaints. 3. **Design Controls (21 CFR 820.30):** Failure to establish procedures for device design control, including risk analysis, design validation, and verification for products like the LiteSaber 10 mm Handpiece and StarLite Fiber Optic devices. The response was inadequate, as retrospective application of controls is required. 4. **Purchasing Controls (21 CFR 820