FDA Inspection
PAR Medizintechnik GmbH & Co. KGPAR Medizintechnik GmbH & Co. KG – FDA Inspection, Jan 16, 2025
Record Details
This FDA Inspection record concerns PAR Medizintechnik GmbH & Co. KG, with an inspection on January 16, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cd5f3161-65ed-41c0-a488-9bcf6995e98d
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1258485
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
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Other FDA inspections of PAR Medizintechnik GmbH & Co. KG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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