FDA Inspection 1014037 — Thorn BioScience LLC
The FDA completed an inspection of Thorn BioScience LLC on May 15, 2017 in Louisville, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 15, 2017
- Fiscal Year
- 2017
- 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 |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 2089 | 21 CFR 211.208 | No records maintained |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |