FDA WARNING_LETTER - ASI Medical, Inc.

On November 29, 2010, an FDA inspection of ASI Medical, Inc. in Centennial, Colorado, revealed that the firm's dental operative units are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. The manufacturing, packing, storage, or installation methods and controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Significant deviations include: 1. **Failure to follow QS Standard Operating Procedures (SOPs)** in multiple areas: * Not maintaining complaint files, documenting investigations, or Medical Device Reporting (MDR) evaluations (21 CFR 820.198). * Not controlling nonconforming product; no Quality Control Exception Reports created despite defective units (21 CFR 820.90(a)). * Not preparing Corrective Action Request forms to initiate corrective actions (21 CFR 820.100(a)(1)). * Not including test certificates in device history records; specific testing not conducted since December 2008 (21 CFR 8020.80(d)). * Not documenting acceptance of incoming products (21 CFR 820.80(b)). * Not conducting management reviews of