FDA Inspection 881948 — Braintree Laboratories, Inc.
The FDA completed an inspection of Braintree Laboratories, Inc. on June 4, 2014 in Braintree, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 4, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Braintree, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 8921 | 21 CFR 314.81(b)(2)(vii)(a) | Post marketing study status report required information |