Xoran Technologies Inc – FDA Warning Letter, Oct 26, 2007

On March 25, 2008, the FDA issued a Warning Letter to Xoran Technologies, Inc. following an inspection from August 30, 2007, to October 26, 2007. The inspection found that the firm's MiniCAT CT System, a medical device, was adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act, due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System regulation (21 CFR Part 820).

Violations included: 1. Failure to document design validation results in Design History Files (21 CFR § 820.30(g)). 2. Failure to maintain a complete Device Master Record (21 CFR § 820.181). 3. Failure to document proper installation procedures and results (21 CFR § 820.170(b)). 4. Failure to maintain Device History Records with primary identification labels (21 CFR § 820.184(e)). 5. Failure to control document approval and distribution (21 CFR § 820.40(a)). 6. Failure to validate and document computer software used in production or the quality system (21 CFR § 820.70(i)).