FDA Inspection 817188 — Imu-Tek Animal Health, Incorporated
The FDA completed an inspection of Imu-Tek Animal Health, Incorporated on Feb 4, 2013 in Fort Collins, CO. 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). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 4, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Fort Collins, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15586 | 21 CFR 111.155(e) | Components - contamination, deterioration, mix-ups |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |