FDA Inspection 1042622 — Braintree Laboratories, Inc.
The FDA completed an inspection of Braintree Laboratories, Inc. on February 28, 2018 in Holbrook, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 28, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Holbrook, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2618 | 21 CFR 211.198(b)(1) | Complaint Record required information |
| 3566 | 21 CFR 211.84(c)(4) | Composite sample top/middle/bottom |