FDA WARNING_LETTER - Amplion Clinical Communications Inc - November 04, 2013

On October 28-30 and November 4, 2013, the FDA inspected Amplion Clinical Communications, Inc., a manufacturer of the Class II Amplion Alert System. The inspection found the device adulterated under 21 USC 351(h) because manufacturing, packing, storage, or installation methods did not conform to Quality System (QS) regulation (21 CFR Part 820). The firm's November 22, 2013, response to the FDA 483 was evaluated.

Violations included: 1. Failure to establish and implement quality audit procedures and conduct audits (21 CFR 820.22). 2. Failure to implement purchasing control procedures and maintain records of acceptable suppliers (21 CFR 820.50). 3. Failure to establish and maintain adequate design control procedures (21 CFR 820.30(a)(1)). 4. Failure to establish corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)). 5. Failure to establish and maintain a Design History File (DHF) (21 CFR 820.30(j)). 6. Failure to maintain Device Master Records (DMRs) (21 CFR 820.181). 7. Failure to