FDA Inspection 1296070 — KaryoLogic Inc
The FDA completed an inspection of KaryoLogic Inc on December 19, 2025 in Durham, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 19, 2025
- Fiscal Year
- 2026
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Durham, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |