FDA Inspection
Nutek Orthopaedics, Inc.Nutek Orthopaedics, Inc. – FDA Inspection, Sep 12, 2014
Record Details
This FDA Inspection record concerns Nutek Orthopaedics, Inc., with an inspection on September 12, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Nutek Orthopaedics, Inc.
- Inspection Date
- September 12, 2014
- Product Type
- Devices
View Company Profile
ID · 96940845-d43c-4bb4-ad44-80ac7f07d3c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 895261
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
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Other FDA inspections of Nutek Orthopaedics, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2024 | NAI | Florida District Office | Postmarket Assurance: Medical Devices |
| March 9, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 4, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 4, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Nutek Orthopaedics, Inc.
- FDA Inspection 1254551 - 2024-11-19
- FDA Inspection 1199695 - 2023-03-09
- FDA Inspection 1036749 - 2018-01-04
- FDA Inspection 753056 - 2011-11-04
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