FDA Inspection
3M3M – FDA Inspection, Apr 17, 2019
Record Details
This FDA Inspection record concerns 3M, with an inspection on April 17, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ff7e8a49-56ce-4786-a9a2-f50d7f4a8cb3
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1087946
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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