Safer Sleep, LLC – FDA Warning Letter, Nov 20, 2007

During a November 2007 inspection, the FDA determined Safer Sleep, LLC's SAFERsleep device is adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act (the Act) because its manufacturing, packing, storage, or installation methods do not conform with the Quality System regulation (21 CFR 820).

Violations include: 1. Failure to establish and maintain procedures for validating device design, including software validation (21 CFR 820.30(g)). 2. Failure to establish and maintain corrective and preventive action procedures (21 CFR 820.100). 3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints, including determining reportable events (21 CFR 820.198). 4. Failure to establish and maintain procedures for acceptance activities, including finished device, incoming product, and returned hardware (21 CFR 820.80). 5. Failure to establish and maintain installation, inspection, and test procedures (21 CFR 820.170(a)). 6. Failure to establish and maintain procedures to ensure purchased products and services conform to requirements (21 CFR 820.50). 7. Failure to establish and maintain procedures to control all required documents (21 CFR 820.