FDA Inspection
Tex-Care MedicalTex-Care Medical – FDA Inspection, Dec 15, 2023
Record Details
This FDA Inspection record concerns Tex-Care Medical, with an inspection on December 15, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2865861e-697e-4c82-84e4-44cf9eb2d0b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1225112
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.80(c)Documentation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.80(c)Documentation
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Other FDA inspections of Tex-Care Medical
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 13, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Tex-Care Medical
- FDA Inspection 1041794 - 2018-01-23
- FDA Inspection 932485 - 2015-05-13
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