FDA Inspection 1153937 — Emergent Biodefense Operations Lansing LLC
The FDA completed an inspection of Emergent Biodefense Operations Lansing LLC on September 29, 2021 in Lansing, MI. 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
- September 29, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Lansing, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |