Axis Health Care LLC – FDA Warning Letter, May 21, 2010

On May 18-21, 2010, an FDA inspection of axis Health Care, LLC, located in Montgomery, Alabama, revealed that their Picture Archive and Communication System (PACS) device is adulterated and misbranded. The PACS device is adulterated because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) and its manufacturing processes do not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR 820). It is misbranded due to failure to notify FDA of intent to introduce the device into commercial distribution (510(k) premarket notification) and failure to furnish required material or information under Section 519 of the Act and 21 CFR 803 MDR regulation.

Specific violations of 21 CFR 820 include: 1. Failure to establish and maintain adequate design control procedures (820.30(a)(1)). 2. Failure to establish and maintain a Design History File (DHF) (820.30(j)). 3. Failure to establish and maintain adequate corrective and preventive action (CAPA) procedures (820.100(a)). 4. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints, including incomplete complaint records (820.198(a