FDA Inspection 1147984 — Orca Biotech LLC
The FDA completed an inspection of Orca Biotech LLC on August 5, 2021 in Sandy, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 5, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Sandy, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |