FDA Inspection 1178720 — APEX Biologix, LLC
The FDA completed an inspection of APEX Biologix, LLC on September 1, 2022 in Woods Cross, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 1, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Woods Cross, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |