FDA Inspection 755765 — Northeast Laboratories, Inc.
The FDA completed an inspection of Northeast Laboratories, Inc. on December 2, 2011 in Rocky Hill, CT. 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
- December 2, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rocky Hill, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |