FDA Inspection
Orfit Industries NVOrfit Industries NV – FDA Inspection, Nov 10, 2022
Record Details
This FDA Inspection record concerns Orfit Industries NV, with an inspection on November 10, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Orfit Industries NV
- Inspection Date
- November 10, 2022
- Product Type
- Devices
View Company Profile
ID · a0572816-474c-443d-9234-544801849198
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1190273
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Orfit Industries NV
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2026 | VAI | Office of Inspections and Investigations | Compliance: Devices |
| May 17, 2018 | VAI | Center for Devices and Radiological Health | Compliance: 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 1052280 - 2018-05-17
- FDA Inspection 925777 - 2015-02-19
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