FDA Inspection
Biegler GmbHBiegler GmbH – FDA Inspection, Apr 18, 2024
Record Details
This FDA Inspection record concerns Biegler GmbH, with an inspection on April 18, 2024, covering devices.
- Company
- Biegler GmbH
- Inspection Date
- April 18, 2024
- Product Type
- Devices
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ID · 5244fdd9-f9e4-49e4-aa25-b3f286457914
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1236227
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Biegler GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 7, 2018 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| January 22, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biegler GmbH
- FDA Inspection 1055388 - 2018-06-07
- FDA Inspection 916609 - 2015-01-22
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