FDA Inspection 1197718 — SSM-SLUH, Inc.
The FDA completed an inspection of SSM-SLUH, Inc. on Feb 17, 2023 in Saint Louis, MO. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 17, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic 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 |