FDA Inspection
Osteolife Biomedical I LLCOsteolife Biomedical I LLC – FDA Inspection, Nov 28, 2018
Record Details
This FDA Inspection record concerns Osteolife Biomedical I LLC, with an inspection on November 28, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 32fed49c-542d-4511-bac7-6f630477eced
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1072837
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 1271.210(d)(2)Verification elements
- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.250(a)Controlling the labeling of HCT/Ps
- 21 CFR 1271.230(a)Validation & approval--established procedures
- 21 CFR 1271.265(c)(1)Release criteria verified, documented
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Other FDA inspections of Osteolife Biomedical I LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2026 | Not classified | Florida District Office | Human Cellular, Tissue, and Gene Therapies |
| February 14, 2023 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| February 4, 2022 | OAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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