FDA Inspection 906257 — Bimeda MTC Animal Health Inc.
The FDA completed an inspection of Bimeda MTC Animal Health Inc. on Nov 21, 2014 in Cambridge. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 21, 2014
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Cambridge (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1933 | 21 CFR 211.167(a) | Sterility/pyrogens - test methods written, followed |
| 2406 | 21 CFR 211.194(a)(8) | Identification of Person Performing Review of Lab Records |
| 4412 | 21 CFR 211.194(a)(7) | Signatures and dates--person who performs test |