FDA WARNING_LETTER - X-Ray Support, Inc. - May 24, 2011

On May 20, 2011, an FDA inspection of a firm in Spokane Valley, Washington, revealed that its Dental X-Ray Automatic Film Processors are adulterated under 21 U.S.C. § 351(h) because manufacturing methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820). The firm's May 24, 2011, email response to the FDA 483 stated it would cease building the device and requested removal from the FDA list, but did not formally address each observation. Subsequent website reviews on June 14 and September 7, 2011, showed the device was still for sale, indicating continued manufacturing and distribution.

Violations of the QS regulation include: 1. Failure to establish and maintain procedures for corrective and preventive actions (21 CFR 820.100(a)). 2. Failure to establish and maintain procedures for design control (21 CFR 820.30(a)). 3. Failure to establish and maintain procedures for purchasing controls (21 CFR 820.50). 4. Failure to establish and maintain procedures to control all documents (21 CFR 820.40). 5. Failure to establish procedures for quality audits and conduct them (21 CFR