Light-Tech, Inc. – FDA Warning Letter, Aug 9, 2011

On December 9, 2011, the FDA issued a Warning Letter to Light-Tech, Inc. following an inspection from August 8-9, 2011, which found their 700 series LED Surgical Lamps to be adulterated and misbranded. The devices were deemed adulterated under Section 501(h) of the Act for non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. Failure to establish and maintain adequate design control procedures (21 CFR 820.30(a)). 2. Failure to establish and maintain adequate procedures for design changes, including the transition from halogen to LED illuminators, and incorporating labeling/risk analysis (21 CFR 820.30(i)). 3. Failure to establish and maintain adequate procedures for purchasing controls and supplier audits (21 CFR 820.50). 4. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)). 5. Failure to establish and maintain adequate procedures for acceptance activities, including verifying LED illuminator specifications and documenting power supply testing (21 CFR 820.80(a)). 6. Failure to establish and maintain adequate procedures for corrective and preventive actions (CAPA), lacking