FDA Inspection
Orthopedic Designs North America, Inc.Orthopedic Designs North America, Inc. – FDA Inspection, Jun 12, 2019
Record Details
This FDA Inspection record concerns Orthopedic Designs North America, Inc., with an inspection on June 12, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 96c500bb-780a-4fee-95bc-6cce0a6665a6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092720
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Orthopedic Designs North America, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 18, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 8, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Orthopedic Designs North America, Inc.
- FDA Inspection 1220268 - 2023-10-05
- FDA Inspection 895589 - 2014-09-18
- FDA Inspection 728487 - 2011-06-08
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