FDA Inspection
3M Company3M Company – FDA Inspection, Jan 6, 2010
Record Details
This FDA Inspection record concerns 3M Company, with an inspection on January 6, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- 3M Company
- Inspection Date
- January 6, 2010
- Product Type
- Devices
View Company Profile
ID · a82d15a6-7967-4d20-a728-c4f7735803cb
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 631143
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of 3M Company
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 25, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 28, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 11, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for 3M Company
- FDA Inspection 996478 - 2016-12-06
- FDA Inspection 883312 - 2014-04-25
- FDA Inspection 828734 - 2013-03-28
- FDA Inspection 588508 - 2009-06-11
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