FDA Inspection
Biotex Inc.Biotex Inc. – FDA Inspection, Aug 23, 2018
Record Details
This FDA Inspection record concerns Biotex Inc., with an inspection on August 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8f7b61cd-b0d1-4cd7-8f69-ca2b6def2447
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063111
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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Other FDA inspections of Biotex Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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