FDA WARNING_LETTER - AES Optics - May 20, 2010

On May 13, 18, and 20, 2010, an FDA inspection of AES Optics in Senatobia, Mississippi, identified the firm as the manufacturer of UVA and UVB protection sunglasses, classified as medical devices. The inspection revealed these devices are adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act (21 USC 351(h)) because manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Violations noted on a Form FDA 483 include: 1. Failure to establish a quality plan (21 CFR 820.20(d)), lacking agreements with contract manufacturers regarding specifications, interaction, and non-conformance reporting. 2. Failure to establish written procedures for third-party quality audits (21 CFR 820.22), despite a third party performing quality testing. 3. Failure to establish written Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(b)) for product failure. 4. Failure to establish and identify valid statistical techniques for UV testing (21 CFR 820.250(a)), with no agreement or procedures for finished device testing. 5. Failure to establish and implement Medical