FDA Inspection 1028718 — 3M U.K., PLC
The FDA completed an inspection of 3M U.K., PLC on Oct 6, 2017 in Newton Aycliffe. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 6, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Newton Aycliffe (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3159 | 21 CFR 820.184 | DHR content |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |