FDA WARNING_LETTER - Compass International Innovations Inc. - March 07, 2011

During a March 3-7, 2011 inspection, the FDA found Compass International Innovations Inc., a manufacturer of stereotactic position and CT stereotactic adaptation systems, in violation of the Quality System (QS) regulation (21 CFR Part 820). These devices are considered adulterated under section 501(h) of the Act due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements.

Key violations include: 1. **Failure to validate device design (software validation)** (21 CFR 820.30(g)): No software validation procedure or plan for software version 12.1. Retrospective validation for versions 10.14-12.1 lacked typical activities like updated software requirements, source code evaluation, and user site testing. 2. **Failure to maintain complaint files** (21 CFR 820.198): The complaint procedure (CII-RA-003) and form (CII-RA-F-100) were not implemented. Customer communications were not identified or processed as complaints, leading to no evaluation for reportable events or documented investigations. 3. **Failure to evaluate and select suppliers** (21 CFR 820.50(a)(2)): No supplier evaluation or qualification activities were performed or documented. 4. **Failure to control noncon