FDA Inspection
Orthopedic Designs North America, Inc.Orthopedic Designs North America, Inc. – FDA Inspection, Jun 8, 2011
Record Details
This FDA Inspection record concerns Orthopedic Designs North America, Inc., with an inspection on June 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 8, 2011
- Product Type
- Devices
View Company Profile
ID · 96aa8fbf-160e-435a-b299-f947a1a18e33
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 728487
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 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 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.17Lack of Written MDR 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 |
| June 12, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 18, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Orthopedic Designs North America, Inc.
- FDA Inspection 1220268 - 2023-10-05
- FDA Inspection 1092720 - 2019-06-12
- FDA Inspection 895589 - 2014-09-18
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