FDA Inspection
Moeller Medical GmbHMoeller Medical GmbH – FDA Inspection, Jan 30, 2014
Record Details
This FDA Inspection record concerns Moeller Medical GmbH, with an inspection on January 30, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Moeller Medical GmbH
- Inspection Date
- January 30, 2014
- Product Type
- Devices
View Company Profile
ID · e11a58d6-aefc-4c55-8d24-3a09fecabe81
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 864721
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.30(c)Design input procedures - addressing conflicting requirement
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.30(i)Design changes - validation vs. verification
- 21 CFR 820.30(g)Design validation - production units
- 21 CFR 820.184(e)ID label, labeling
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.100(a)(4)Verification vs validation
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Other FDA inspections of Moeller Medical GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 22, 2018 | Not classified | Office of Inspections and Investigations |
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