FDA Inspection
AB MEDICA SASFDA Inspection 953977 - AB MEDICA SAS - December 10, 2015
Record Details
This FDA Inspection record concerns AB MEDICA SAS, with an inspection on December 10, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- AB MEDICA SAS
- Inspection Date
- December 10, 2015
- Product Type
- Devices
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ID · 1e822cb8-b8a6-43eb-ba51-44d35ed392a2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 953977
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Complaints
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Other FDA inspections of AB MEDICA SAS
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 28, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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