FDA Inspection 1073085 — TechMix LLC
The FDA completed an inspection of TechMix LLC on November 28, 2018 in Fennimore, WI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 28, 2018
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Fennimore, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15648 | 21 CFR 111.465(a)(2) | Hold - reserve sample; closure system |
| 15708 | 21 CFR 111.325(a) | Written procedures, laboratory operations |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |