FDA WARNING_LETTER - Eaton Manufacturing Corporation Dba Eaton Medical - June 25, 2010

On June 23 & 25, 2010, an FDA inspection of Eaton Manufacturing Corporation dba Eaton Medical in Memphis, Tennessee, determined the company manufactures post mydriatic protective eyewear and contact lens cases, which are medical devices. The devices are adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act because their manufacturing, packing, storage, or installation methods, facilities, or controls do not conform with 21 CFR Part 820, Quality System (QS) regulations.

A Form FDA 483, Inspectional Observations, was issued on June 25, 2010. Serious deviations include: 1. Failure to establish QS procedures and instructions [21 CFR 820.20(e)]. 2. Failure to develop and implement Medical Device Reporting procedures [21 CFR 803.17]. 3. Failure to establish written procedures for Corrective and Preventive Action [21 CFR 820.100(a)]. 4. Failure to establish and implement written procedures for acceptance of incoming products [21 CFR 820.80(b)]. 5. Failure to establish written procedures for receiving, reviewing, and evaluating complaints [21 CFR 820.198(a)]. 6. Failure to establish written procedures to ensure all purchased or received product and services conform to