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FDA Inspection
•3M Company - Health Care Business•February 11, 2019

3M Company - Health Care Business – FDA Inspection, Feb 11, 2019

Record Details

This FDA Inspection record concerns 3M Company - Health Care Business, with an inspection on February 11, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
3M Company - Health Care Business
Inspection Date
February 11, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Kellie L. Thommes (FDA Associated Person)
View Company Profile

ID · 74e1eadc-5192-45c0-88b5-7b7121363146

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1081355
FDA center
Human Drugs
Project area
Bioresearch Monitoring
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 314.80(c)(2)Failure to report non-alert ADEs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of 3M Company - Health Care Business

9
DateClassificationOfficeProject area
February 7, 2025Not classifiedMinneapolis District Office
December 21, 2017Not classifiedMinneapolis District Office
June 16, 2017Not classifiedMinneapolis District Office
May 17, 2017VAICenter for Drug Evaluation and ResearchPostmarket Surv. and Epidemiology
December 8, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
View all 9 other inspections on the company page
Other documents for 3M Company - Health Care Business
  • FDA Inspection 1228933 - 2025-02-07
  • FDA Inspection 1051232 - 2017-12-21
  • FDA Inspection 1030736 - 2017-06-16
  • FDA Inspection 1017823 - 2017-05-17
  • FDA Inspection 996493 - 2016-12-08

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