FDA Inspection
Pfm Medical Cpp SAPfm Medical Cpp SA – FDA Inspection, Jan 12, 2023
Record Details
This FDA Inspection record concerns Pfm Medical Cpp SA, with an inspection on January 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 0e7499ad-cdd5-4091-a99d-7999e49cc224
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195165
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of Pfm Medical Cpp SA
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2018 | Not classified | Office of Inspections and Investigations | |
| November 30, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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