FDA Inspection
Med-Tex, LLC dba Med TextileMed-Tex, LLC dba Med Textile – FDA Inspection, Jul 18, 2019
Record Details
This FDA Inspection record concerns Med-Tex, LLC dba Med Textile, with an inspection on July 18, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 49b6c9e9-1003-451f-9017-cc9568b77305
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1097049
- 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 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Med-Tex, LLC dba Med Textile
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 3, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 9, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Med-Tex, LLC dba Med Textile
- FDA Inspection 1004685 - 2017-03-03
- FDA Inspection 813500 - 2013-01-09
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