FDA Inspection 983235 — Northeast Laboratory Services, Inc.
The FDA completed an inspection of Northeast Laboratory Services, Inc. on August 17, 2016 in Winslow, ME. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 17, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Winslow, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3837 | 21 CFR 820.25(b) | Training records |