FDA Inspection
3M U.K., PLC3M U.K., PLC – FDA Inspection, Oct 6, 2017
Record Details
This FDA Inspection record concerns 3M U.K., PLC, with an inspection on October 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Shafiq Ahadi (Issuing Officer)
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ID · c32c3730-2f9d-4bac-9f8f-1c8a2fc9eff9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028718
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.80(e)Documentation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of 3M U.K., PLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for 3M U.K., PLC
- FDA Inspection 1178717 - 2022-07-27
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