FDA Inspection
PFM Medical Mepro GMBHPFM Medical Mepro GMBH – FDA Inspection, Jan 26, 2023
Record Details
This FDA Inspection record concerns PFM Medical Mepro GMBH, with an inspection on January 26, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3e620180-83ca-42c5-85bc-6b6594bae82b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1198107
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.17(b)(4)Info which facilitates timely FDA follow-up
- 21 CFR 803.17(b)(4)Info which facilitates timely FDA follow-up
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of PFM Medical Mepro GMBH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for PFM Medical Mepro GMBH
- FDA Inspection 1067796 - 2018-08-30
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