FDA Inspection
Osseolink USA, LLCOsseolink USA, LLC – FDA Inspection, Jun 25, 2014
Record Details
This FDA Inspection record concerns Osseolink USA, LLC, with an inspection on June 25, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Osseolink USA, LLC
- Inspection Date
- June 25, 2014
- Product Type
- Devices
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ID · afbdc3ac-8491-4baa-8fa7-65c515c16341
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 884639
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.198(a)Complaints
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Osseolink USA, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 18, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 29, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 19, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 8, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Osseolink USA, LLC
- FDA Inspection 1145622 - 2021-06-10
- FDA Inspection 1099236 - 2019-06-18
- FDA Inspection 863826 - 2014-01-29
- FDA Inspection 764359 - 2012-01-19
- FDA Inspection 640016 - 2010-01-08
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