FDA Inspection 941530 — Boston Analytical, Inc.
The FDA completed an inspection of Boston Analytical, Inc. on June 23, 2015 in Salem, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 23, 2015
- Fiscal Year
- 2015
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Salem, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4403 | 21 CFR 211.194(b) | Test method modification records do not include |