FDA WARNING_LETTER - American Quality Manufacturing, Inc. - March 29, 2011

On August 9, 2011, the FDA issued a Warning Letter to American Quality Manufacturing, Inc. following a March 28-29, 2011 inspection. The firm manufactures and distributes Skin Rejuvenation and Sun Tanning Products, which are classified as devices. The inspection revealed these devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) Good Manufacturing Practice (CGMP) requirements.

Violations include: 1. Failure to establish and maintain written CAPA procedures (21 CFR 820.100). 2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)). 3. Failure to establish and maintain quality requirements for suppliers, contractors, and consultants (21 CFR 820.50(a)). 4. Failure to establish procedures for quality audits (21 CFR 820.22). 5. Failure by management to review the quality system's suitability and effectiveness at defined intervals (21 CFR 820.20(c)). 6. Failure to establish and maintain adequate Device History Record (DHR) procedures (21 CFR 820.