FDA Inspection 1197154 — Origin Biologics LLC
The FDA completed an inspection of Origin Biologics LLC on February 10, 2023 in Las Vegas, NV. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 10, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Las Vegas, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12359 | 21 CFR 1271.195(a)(3) | Aseptic processing---cleaning, disinfecting |
| 12372 | 21 CFR 1271.200(c) | Calibrated per established schedules |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |