FDA Inspection
Insulet CorporationInsulet Corporation – FDA Inspection, Oct 25, 2016
Record Details
This FDA Inspection record concerns Insulet Corporation, with an inspection on October 25, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 378be8a2-9f8f-407a-a4af-ac1402a50e15
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991193
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Insulet Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 11, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 19, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 19, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 17, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Insulet Corporation
- FDA Inspection 1042464 - 2018-02-15
- FDA Inspection 954714 - 2015-12-11
- FDA Inspection 848880 - 2013-09-19
- FDA Inspection 756393 - 2011-12-19
- FDA Inspection 694698 - 2010-09-17
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