FDA Inspection 610733 — Bio Agri Mix LP
The FDA completed an inspection of Bio Agri Mix LP on Aug 27, 2009 in Mitchell. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 27, 2009
- Fiscal Year
- 2009
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Mitchell (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2379 | 21 CFR 226.40(e) | Cleaning to prevent contamination of Type A articles |
| 4148 | 21 CFR 226.30(e) | Suitable size and accuracy for intended use |
| 4297 | 21 CFR 226.42(a) | Components receiving, testing, handling, et. al. |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |