FDA Inspection 917843 — Intervet GesmbH
The FDA completed an inspection of Intervet GesmbH on Feb 27, 2015 in Vienna. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 8 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 27, 2015
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Vienna (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |