FDA Inspection
Medisize bvMedisize bv – FDA Inspection, Aug 15, 2013
Record Details
This FDA Inspection record concerns Medisize bv, with an inspection on August 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medisize bv
- Inspection Date
- August 15, 2013
- Product Type
- Devices
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ID · 1238243b-3cee-4037-9489-e13f511776bd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 844546
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
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Other FDA inspections of Medisize bv
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 23, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 4, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medisize bv
- FDA Inspection 982629 - 2016-05-23
- FDA Inspection 700375 - 2010-11-04
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