FDA Inspection 1052929 — Thorn BioScience LLC
The FDA completed an inspection of Thorn BioScience LLC on May 23, 2018 in Louisville, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 23, 2018
- Fiscal Year
- 2018
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Louisville, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1977 | 21 CFR 211.182 | Dedicated equipment: records part of batch record |
| 2089 | 21 CFR 211.208 | No records maintained |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |