FDA Inspection
Bernstein AGBernstein AG – FDA Inspection, Feb 26, 2009
Record Details
This FDA Inspection record concerns Bernstein AG, with an inspection on February 26, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bernstein AG
- Inspection Date
- February 26, 2009
- Product Type
- Devices
View Company Profile
ID · 7099bf31-34d4-4939-ac9c-69e8a3e20fe6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 569728
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(e)Design review procedures - personnel
- 21 CFR 820.181(a)DMR device specifications
- 21 CFR 820.40(a)Document review, approval documentation
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Other FDA inspections of Bernstein AG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 10, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bernstein AG
- FDA Inspection 994375 - 2016-11-10
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