FDA Inspection
RUDOLF Medical GmbH + Co. KGRUDOLF Medical GmbH + Co. KG – FDA Inspection, Feb 22, 2017
Record Details
This FDA Inspection record concerns RUDOLF Medical GmbH + Co. KG, with an inspection on February 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · eec2d86e-ba71-42df-aaaf-48cdb5771bc9
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1003236
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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