FDA WARNING_LETTER - CrystalBraces, LLC. - September 23, 2015

On September 16-23, 2015, the FDA inspected CrystalBraces LLC's facilities in Dallas, Texas, and determined that the CrystalBraces dental aligner is an adulterated device under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). The firm's October 14, 2015, response to the FDA 483 was incomplete.

Violations include: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)), with no documented design inputs, outputs, reviews, verifications, validations, or design transfers for the CrystalBraces aligner, despite having written procedures. 2. Failure to validate computer software for intended use (21 CFR 820.70(i)), specifically for " (b)(4) " and " (b)(4) " used in patient teeth imaging and movement pattern determination, and " (b)(4) " and " (b)(4) " used for converting impressions to compatible file types for mold manufacturing. 3. Failure to develop, conduct, control, and monitor production processes (21 CFR 820.70(a)), lacking procedures for the " (b)(4) " mold creation process and