FDA Inspection 1070670 — Cambridge Sensors Usa, Llc
The FDA completed an inspection of Cambridge Sensors Usa, Llc on Nov 1, 2018 in Plainfield, IL. 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
- Nov 1, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Plainfield, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 4211 | 21 CFR 806.20(b)(3) | Events |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 4213 | 21 CFR 806.20(b)(5) | Records of communications |