FDA Inspection
ORCHID UNIQUEORCHID UNIQUE – FDA Inspection, Nov 1, 2017
Record Details
This FDA Inspection record concerns ORCHID UNIQUE, with an inspection on November 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 0cc56f6d-8676-4628-8f41-6d9d9a87aff6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1030456
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.70(i)Software validation for automated processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ORCHID UNIQUE
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ORCHID UNIQUE
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.