FDA Inspection
OBERON GmbH Fiber TechnologiesFDA Inspection 1260085 - OBERON GmbH Fiber Technologies - February 06, 2025
Record Details
This FDA Inspection record concerns OBERON GmbH Fiber Technologies, with an inspection on February 6, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- February 6, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 68c2e9dd-e356-4fa7-82e0-9a7bbc1c8ff0
Inspection Facts
- Inspection number
- 1260085
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of OBERON GmbH Fiber Technologies
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 13, 2017 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
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