American Aesthetics Medical Supply, Inc. – FDA Warning Letter, Mar 19, 2013

On March 14-19, 2013, an FDA inspection of American Aesthetics Medical Supply, Inc. d/b/a Aesthetics Medical, Inc. in Dallas, Texas, revealed significant violations regarding medical devices and unapproved drugs. The firm manufactures, services, and relabels devices including Microderma S-100 Microdermabrasion System, Microdermabrasion Crystals, Youth 1 Microcurrent with LED Therapy, and BioLight.

The firm's devices are misbranded due to failure to develop, maintain, and implement adequate Medical Device Reporting (MDR) procedures (21 CFR 803.17). Additionally, these devices are adulterated and misbranded because the firm markets them with unapproved claims (e.g., "healing active acne," "tackle wrinkles," "kill the acne bacteria," "wound healing") without premarket clearance or approval (sections 501(f)(1)(B), 502(o), 515(a), 510(k) of the Act). The firm also failed to fulfill annual establishment registration and product listing requirements for fiscal year 2013 (section 502(o) of the Act).

Furthermore, the firm markets unapproved drugs under the SkinBorn label (e.g., Super Antioxidant Cream, Beta & Alpha Hydroxy Acid) with claims indicating drug intended uses (e.g