FDA Inspection
Biokit, S.A.Biokit, S.A. – FDA Inspection, Feb 21, 2013
Record Details
This FDA Inspection record concerns Biokit, S.A., with an inspection on February 21, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biokit, S.A.
- Inspection Date
- February 21, 2013
- Product Type
- Devices
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ID · c724dce8-77b1-4441-bd0f-bc5c90ec673b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 822147
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Biokit, S.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2022 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Biokit, S.A.
- FDA Inspection 1177499 - 2022-07-14
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