FDA Inspection
Orfit Industries NVOrfit Industries NV – FDA Inspection, May 17, 2018
Record Details
This FDA Inspection record concerns Orfit Industries NV, with an inspection on May 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3d2593ec-9f88-4310-8ad4-55a818e24f49
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052280
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(e)Design review - documentation
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Other FDA inspections of Orfit Industries NV
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2026 | VAI | Office of Inspections and Investigations | Compliance: Devices |
| November 10, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 19, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Orfit Industries NV
- FDA Inspection 1311274 - 2026-04-02
- FDA Inspection 1190273 - 2022-11-10
- FDA Inspection 925777 - 2015-02-19
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