FDA Inspection 1162845 — New England Ortho Laboratory, Inc.
The FDA completed an inspection of New England Ortho Laboratory, Inc. on Feb 18, 2022 in Andover, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 18, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Andover, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |