FDA Inspection 1220460 — Alk-abello, Inc.
The FDA completed an inspection of Alk-abello, Inc. on October 17, 2023 in Port Washington, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 17, 2023
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Port Washington, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |