483
Texas Eye Prosthetics, LLCFDA 483 - Texas Eye Prosthetics, LLC
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Record Details
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 The firm's established procedure for calibrating a specific unit is outdated, as the unit is no longer in use and a new unit has been implemented without an updated calibration procedure.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.
- Company
- Texas Eye Prosthetics, LLC
- Product Type
- Device
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ID · 65f9264f-9890-421c-9be5-7434220d245f