FDA Inspection
ORCHID UNIQUEORCHID UNIQUE – FDA Inspection, Sep 5, 2019
Record Details
This FDA Inspection record concerns ORCHID UNIQUE, with an inspection on September 5, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b3deee63-a7fc-4f7b-a6af-981134c5f290
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1101178
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of ORCHID UNIQUE
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2017 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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