FDA Inspection 1072837 — Osteolife Biomedical I LLC
The FDA completed an inspection of Osteolife Biomedical I LLC on November 28, 2018 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 28, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12369 | 21 CFR 1271.200(b) | Procedures inadequate |
| 12381 | 21 CFR 1271.210(d)(2) | Verification elements |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12405 | 21 CFR 1271.250(a) | Controlling the labeling of HCT/Ps |
| 12424 | 21 CFR 1271.265(c)(1) | Release criteria verified, documented |