FDA WARNING_LETTER - Western/Scott Fetzer Company - September 02, 2014

This FDA Warning Letter (CIN-15-441366-03) was issued to Western Enterprises/Scott Fetzer Company, a manufacturer of medical gas pressure and suction regulators, following an inspection from July 10 to September 2, 2014. The inspection revealed that the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to establish and maintain procedures for analyzing quality data (21 CFR 820.100(a)(1)):** The "Corrective Action Procedure" (WEOP0838) inadequately addresses evaluation and analysis of quality data. Only top six complaint and "Line Fallout" codes were evaluated, neglecting others. Scrap was not documented or analyzed, and action/alert limits were not established. Complaint trend codes were undefined and inaccurately documented. The firm's response to revise procedures by November 30, 2014, was noted but deemed inadequate regarding retrospective review of complaints. 2. **Failure to review, evaluate, and investigate complaints (21 CFR 820.198(c)):** An investigation for Complaint #1140314-