FDA Inspection
August Reuchlen GmbHAugust Reuchlen GmbH – FDA Inspection, May 2, 2025
Record Details
This FDA Inspection record concerns August Reuchlen GmbH, with an inspection on May 2, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · dc7ad8ff-799d-4c81-af4b-2134efd5972c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1270229
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of August Reuchlen GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for August Reuchlen GmbH
- FDA Inspection 933097 - 2015-07-02
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