FDA Inspection
Orthopedic Designs North America, Inc.Orthopedic Designs North America, Inc. – FDA Inspection, Sep 18, 2014
Record Details
This FDA Inspection record concerns Orthopedic Designs North America, Inc., with an inspection on September 18, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 18, 2014
- Product Type
- Devices
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ID · cad5f334-3c22-48bc-bbf2-9bc86482a1e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 895589
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 806.20(b)(3)Events
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 806.20(b)(1)Device name, identification
- 21 CFR 820.50(b)Supplier notification of changes
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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 |
| June 12, 2019 | 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 1092720 - 2019-06-12
- FDA Inspection 728487 - 2011-06-08
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