FDA 483 - Stetrix, Inc. - February 06, 2019

An FDA inspection of Sterfix, Inc. in Bartlett, TN, a specification developer, revealed significant deficiencies in its quality system for the Class II Hem-Avert® Perianal Stabilizer. The firm failed to adequately establish procedures for design input, verification, and validation. Additionally, issues were noted with product identification and the absence of documented internal quality audits.