FDA Inspection 1161595 — Osteolife Biomedical I LLC
The FDA completed an inspection of Osteolife Biomedical I LLC on February 4, 2022 in Miami, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 4, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12309 | 21 CFR 1271.160(a) | Program is appropriate for the HCT/Ps |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12367 | 21 CFR 1271.200(a) | Design appropriate, suitably located |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12419 | 21 CFR 1271.265(a) | Evaluation--microorganisms, damage |
| 12426 | 21 CFR 1271.265(c)(2) | Improperly released for distribution |