FDA Inspection
3M Company - Health Care Business3M Company - Health Care Business – FDA Inspection, May 17, 2017
Record Details
This FDA Inspection record concerns 3M Company - Health Care Business, with an inspection on May 17, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · dda3b3a7-3bac-4457-a87b-c53b5b19bf32
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017823
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 314.81(b)(2)Form FDA 2252
- FDCA 760(c)(1)Timing of AE report submission (non-RX drugs)
- FDCA 760(c)(2)New medical information, timing of submission (non-Rx drugs)
- 21 CFR 314.81(b)(2)Timely submission
- FDCA 760(b)(1)No label copy submitted with AE report (non-Rx drug)
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(j)Failure to maintain records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of 3M Company - Health Care Business
9| Date | Classification | Office | Project area |
|---|---|---|---|
| February 7, 2025 | Not classified | Minneapolis District Office | |
| February 11, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 21, 2017 | Not classified | Minneapolis District Office | |
| June 16, 2017 | Not classified | Minneapolis District Office | |
| December 8, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for 3M Company - Health Care Business
- FDA Inspection 1228933 - 2025-02-07
- FDA Inspection 1081355 - 2019-02-11
- FDA Inspection 1051232 - 2017-12-21
- FDA Inspection 1030736 - 2017-06-16
- FDA Inspection 996493 - 2016-12-08
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