FDA Inspection 635771 — Boston Analytical, Inc.
The FDA completed an inspection of Boston Analytical, Inc. on December 23, 2009 in Salem, NH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 23, 2009
- Fiscal Year
- 2010
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Salem, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2035 | 21 CFR 211.194(e) | Stability testing records not included |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |