FDA Inspection
Osseolink USA, LLCOsseolink USA, LLC – FDA Inspection, Jan 8, 2010
Record Details
This FDA Inspection record concerns Osseolink USA, LLC, with an inspection on January 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Osseolink USA, LLC
- Inspection Date
- January 8, 2010
- Product Type
- Devices
View Company Profile
ID · b5a8b790-262c-4255-a07e-bb5879bb26e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 640016
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.30(f)Design verification procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
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 |
| June 25, 2014 | VAI | 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 |
Other documents for Osseolink USA, LLC
- FDA Inspection 1145622 - 2021-06-10
- FDA Inspection 1099236 - 2019-06-18
- FDA Inspection 884639 - 2014-06-25
- FDA Inspection 863826 - 2014-01-29
- FDA Inspection 764359 - 2012-01-19
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