# FDA 483 - Texas Eye Prosthetics, LLC - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/texas-eye-prosthetics-llc/65f9264f-9890-421c-9be5-7434220d245f

> FDA 483 for Texas Eye Prosthetics, LLC on Unknown Date. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Texas Eye Prosthetics, LLC
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Texas Eye Prosthetics LLC in Houston, TX, revealed an issue with equipment calibration procedures. The firm's established procedure for calibrating a specific unit is outdated, as the unit is no longer in use and a new unit has been implemented without an updated calibration procedure. This indicates a lapse in maintaining adequate control over equipment used in device manufacturing.

## Related Documents

- [483 - 2019-08-12](https://www.globalkeysolutions.net/records/483/texas-eye-prosthetics-llc/5caafb6e-c358-4092-b333-bf4f50021ee9)

## Related Officers

- [Amber Smith](https://www.globalkeysolutions.net/people/amber-smith/2395fa1b-d091-4227-a340-9d6991c394fa)

Company: https://www.globalkeysolutions.net/companies/texas-eye-prosthetics-llc/5fa068c0-e42f-43df-b907-c0e68161bfdf

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab