FDA Inspection 1148566 — Lucina BioSciences, LLC
The FDA completed an inspection of Lucina BioSciences, LLC on August 10, 2021 in Aurora, CO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 10, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |