FDA Inspection
Orthobone, Inc.Orthobone, Inc. – FDA Inspection, May 4, 2016
Record Details
This FDA Inspection record concerns Orthobone, Inc., with an inspection on May 4, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Orthobone, Inc.
- Inspection Date
- May 4, 2016
- Product Type
- Biologics
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ID · 13bdb51b-5d39-4360-9edb-b394672f0fdc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 970058
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Orthobone, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 15, 2020 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 16, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 2, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Orthobone, Inc.
- FDA Inspection 1242170 - 2024-06-18
- FDA Inspection 1115375 - 2020-01-15
- FDA Inspection 1065410 - 2018-08-16
- FDA Inspection 770808 - 2012-03-02
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