FDA Inspection 1096541 — Thomas Labs, LLC
The FDA completed an inspection of Thomas Labs, LLC on July 17, 2019 in Tolleson, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 17, 2019
- Fiscal Year
- 2019
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Tolleson, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1957 | 21 CFR 211.180(e)(2) | Review of problem drugs |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4576 | 21 CFR 211.192 | No written record of investigation |