FDA Inspection 1167402 — SSM-SLUH, Inc.
The FDA completed an inspection of SSM-SLUH, Inc. on Apr 19, 2022 in Saint Louis, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 19, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 150 | 21 CFR 606.151(e) | Procedures to maintain records of emergency transfusions |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |