FDA Inspection 1287066 — Imu-Tek Animal Health, Incorporated
The FDA completed an inspection of Imu-Tek Animal Health, Incorporated on October 14, 2025 in Fort Collins, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 14, 2025
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Fort Collins, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15971 | 21 CFR 111.120(a) | Quality control operations - receiving records |
| 22811 | 21 CFR 111.453 | Written procedures - establish; holding and distribution |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22860 | 21 CFR 111.103 | Written procedures - follow; quality control operations |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22890 | 21 CFR 111.260 | Batch record - required information |