# FDA 483 - Blephex, LLC - March 28, 2019

Source: https://www.globalkeysolutions.net/records/483/blephex-llc/9550a68d-91a0-4c00-a153-9eaddda8f0fa

> FDA 483 for Blephex, LLC on March 28, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Blephex, LLC
- Inspection Date: 2019-03-28
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of Blephex, LLC in Franklin, TN, identified two significant observations. The firm failed to establish adequate procedures for receiving, reviewing, and evaluating complaints. Additionally, Blephex, LLC lacked written Medical Device Reporting (MDR) procedures, indicating a need for improved quality system documentation and implementation.

## Related Officers

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

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

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