FDA Inspection 1156436 — Alevio, LLC
The FDA completed an inspection of Alevio, LLC on November 10, 2021 in Cullman, AL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 10, 2021
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Cullman, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |