FDA WARNING_LETTER - Mir-Com Products LLC - June 07, 2012

On June 7, 2012, an FDA inspection of Mir-Com Products LLC in Central City, PA, revealed that the firm manufactures the Kennedy Decompression Technique (KDT) and KDT Neural-Flex devices and distributes the K-Laser USA device. The KDT and KDT Neural-Flex devices were found to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. Failure to establish and maintain corrective and preventive action procedures (21 CFR 820.100(a)). 2. Failure to establish and maintain purchasing control procedures (21 CFR 820.50). 3. Failure to establish and maintain complaint handling procedures and a complaint file (21 CFR 820.198(a)). 4. Failure to establish a quality policy and objectives (21 CFR 820.20(a)). 5. Failure to establish quality audit procedures or conduct audits (21 CFR 820.22). 6. Failure to maintain Device Master Records (DMR) for KDT and KDT Neural-Flex devices (21 CFR 820.181). 7. Failure to maintain Device History Records (DHR) for KDT