FDA Inspection
Rudischhauser Surgical Instruments Manufacturing GmbHRudischhauser Surgical Instruments Manufacturing GmbH – FDA Inspection, Dec 8, 2016
Record Details
This FDA Inspection record concerns Rudischhauser Surgical Instruments Manufacturing GmbH, with an inspection on December 8, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 8, 2016
- Product Type
- Devices
View Company Profile
ID · c8ec8abd-8a35-408b-b075-3320251af15a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 995720
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Rudischhauser Surgical Instruments Manufacturing GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 4, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Rudischhauser Surgical Instruments Manufacturing GmbH
- FDA Inspection 1180922 - 2022-09-21
- FDA Inspection 859239 - 2013-12-04
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