FDA Inspection 1115784 — Boston Analytical, Inc.
The FDA completed an inspection of Boston Analytical, Inc. on January 24, 2020 in Salem, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 24, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salem, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |