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

Source: https://www.keypedia.com/records/483/stetrix-inc/5cd0bc4f-1c21-4661-a58b-4c99f640c5cb

> FDA 483 for Stetrix, Inc. on February 06, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stetrix, Inc.
- Inspection Date: 2019-02-06
- Product Type: device
- Office Name: New Orleans District Office
- Summary: 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.

## Related Officers

- [Mary A. Millner](https://www.keypedia.com/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

Company: https://www.keypedia.com/companies/stetrix-inc/244d57a2-ba6d-4ec1-b698-e58a05280b18

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea