FDA Inspection 844750 — Bimeda, Inc.
The FDA completed an inspection of Bimeda, Inc. on Aug 16, 2013 in Le Sueur, MN. 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). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 16, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Le Sueur, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 3445 | 21 CFR 211.65(a) | Equipment construction - reactive surfaces |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |