FDA WARNING_LETTER - Nouritress Hair Products, LLC - November 02, 2012

On November 2, 2012, an FDA inspection of a firm in Fayetteville, Georgia, revealed that the NouriLaser laser hair comb, imported and manufactured by the firm, is an adulterated and misbranded device.

Violations of the Quality System regulation (21 CFR Part 820) include: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)). 2. Failure to develop, conduct, control, and monitor production processes to ensure device conformity to specifications, lacking documented instructions, labeling procedures, and inspection/testing (21 CFR 820.70(a)). 3. Failure to establish and maintain corrective and preventive action procedures (21 CFR 820.100(a)). 4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)). 5. Failure of management with executive responsibility to establish a policy and objectives for, and commitment to, quality (21 CFR 820.20(a)).

The device is also adulterated because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption (21 U.S.C. § 351(f)(1)(B)). It is misbranded due to failure to notify the FDA