FDA Inspection 1240885 — Mixlab TX LLC
The FDA completed an inspection of Mixlab TX LLC on August 2, 2024 in Weatherford, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 2, 2024
- Fiscal Year
- 2024
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Weatherford, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1869 | 21 CFR 211.94(c) | Containers & Closures Clean, Sterilized, Pyrogen-free |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1932 | 21 CFR 211.167(a) | Sterility/pyrogen-free testing |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |