FDA Inspection 1273221 — Diagnostic Services Of Kansas State, Inc.
The FDA completed an inspection of Diagnostic Services Of Kansas State, Inc. on June 20, 2025 in Manhattan, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 20, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Manhattan, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |