FDA Inspection
Biegler GmbHBiegler GmbH – FDA Inspection, Jun 7, 2018
Record Details
This FDA Inspection record concerns Biegler GmbH, with an inspection on June 7, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 9370acf1-0c33-42d9-a4be-e73b8fde094f
Inspection Facts
- Inspection number
- 1055388
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 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 |
|---|---|---|---|
| April 18, 2024 | VAI | Compliance: Devices | |
| January 22, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biegler GmbH
- FDA Inspection 1236227 - 2024-04-18
- FDA Inspection 916609 - 2015-01-22
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