FDA Inspection 1273221 — Diagnostic Services Of Kansas State, Inc.
The FDA completed an inspection of Diagnostic Services Of Kansas State, Inc. on Jun 20, 2025 in Manhattan, KS. 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
- Jun 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 |