FDA Inspection 634723 — Strategic Veterinary Pharmaceuticals, Inc.
The FDA completed an inspection of Strategic Veterinary Pharmaceuticals, Inc. on Nov 23, 2009 in Saint Joseph, MO. 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). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 23, 2009
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Saint Joseph, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 3550 | 21 CFR 211.46(c) | Exhaust systems inadequate to control air contamination |