FDA Inspection
Thompson Ocular Prosthetics, IncThompson Ocular Prosthetics, Inc – FDA Inspection, Nov 16, 2016
Record Details
This FDA Inspection record concerns Thompson Ocular Prosthetics, Inc, with an inspection on November 16, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fa5a22c0-8bd0-4ba4-a3af-8c49cbfc66a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995474
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
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Other FDA inspections of Thompson Ocular Prosthetics, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2025 | NAI | Dallas District Office | Postmarket Assurance: Medical Devices |
| March 6, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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