FDA Inspection 1070323 — Alk-abello, Inc.
The FDA completed an inspection of Alk-abello, Inc. on October 30, 2018 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 30, 2018
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Port Washington, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |