FDA Inspection
Baitella AGBaitella AG – FDA Inspection, Feb 2, 2012
Record Details
This FDA Inspection record concerns Baitella AG, with an inspection on February 2, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Baitella AG
- Inspection Date
- February 2, 2012
- Product Type
- Devices
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ID · a8df721e-9ab2-4b1f-9108-211e4bb6c681
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 770268
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Baitella AG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 18, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Baitella AG
- FDA Inspection 1272814 - 2025-05-15
- FDA Inspection 972333 - 2016-05-18
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