Oregon Aesthetic Technologies, Inc. – FDA Warning Letter, Jun 21, 2012

On September 14, 2012, the FDA issued a Warning Letter to Oregon Aesthetic Technologies, Inc. (DBA ANSR) following an inspection from June 12-21, 2012. The inspection revealed that the ANSR: BEAM and ANSR: HALO devices are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. Failure to establish and maintain procedures for corrective and preventive action (21 CFR 820.100(a)). 2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)). 3. Failure to establish and maintain procedures to control device design (21 CFR 820.30(a)). 4. Failure to establish and maintain procedures to control nonconforming product (21 CFR 820.90(a)). 5. Failure to adequately evaluate and select suppliers, contractors, and consultants (21 CFR 820.50(a)(1)). 6. Failure to maintain device master records (21 CFR 820.181).