FDA Inspection 1197718 — SSM-SLUH, Inc.
The FDA completed an inspection of SSM-SLUH, Inc. on February 17, 2023 in Saint Louis, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 17, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |