FDA Inspection
Rudischhauser Surgical Instruments Manufacturing GmbHRudischhauser Surgical Instruments Manufacturing GmbH – FDA Inspection, Sep 21, 2022
Record Details
This FDA Inspection record concerns Rudischhauser Surgical Instruments Manufacturing GmbH, with an inspection on September 21, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 21, 2022
- Product Type
- Devices
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ID · f1e809e1-625a-4ce6-893a-2c570fc1a563
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1180922
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.184DHR content
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Other FDA inspections of Rudischhauser Surgical Instruments Manufacturing GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 4, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Rudischhauser Surgical Instruments Manufacturing GmbH
- FDA Inspection 995720 - 2016-12-08
- FDA Inspection 859239 - 2013-12-04
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