# FDA 483 - Blephex, LLC - November 19, 2025

Source: https://www.keypedia.com/records/483/blephex-llc/27ae88e7-1677-401a-850a-5582a8bc1254

> FDA 483 for Blephex, LLC on November 19, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Blephex, LLC
- Inspection Date: 2025-11-19
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Blephex, LLC, a medical device developer/manufacturer in Brentwood, TN, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately maintain complaint files, document corrective actions, and establish essential procedures for design control, device history records, training, and quality audits. These issues indicate a broad lack of foundational quality system controls.

## Related Documents

- [483 - 2019-03-28](https://www.keypedia.com/records/483/blephex-llc/9550a68d-91a0-4c00-a153-9eaddda8f0fa)
- [WARNING_LETTER - 2025-11-19](https://www.keypedia.com/records/warning_letter/blephex-llc/2c366a67-26ed-42de-ac82-96baa76f8cbe)

## Related Officers

- [investigator](https://www.keypedia.com/people/nikki-s-bryant/fe859d4f-23a6-4bc9-94c6-5b3c3fe8d99a)

Company: https://www.keypedia.com/companies/blephex-llc/6b7dcf51-492e-4727-a45d-76eb290952ab

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