483
Stetrix, Inc.Stetrix, Inc. – FDA 483, Feb 6, 2019
Record Details
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.
- Person
View Company Profile
ID · 5cd0bc4f-1c21-4661-a58b-4c99f640c5cb
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.