FDA Inspection
Insulet CorporationInsulet Corporation – FDA Inspection, Sep 19, 2013
Record Details
This FDA Inspection record concerns Insulet Corporation, with an inspection on September 19, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Insulet Corporation
- Inspection Date
- September 19, 2013
- Product Type
- Devices
View Company Profile
ID · 43b9f067-4495-4db8-bb74-11e5ab5fef50
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848880
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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 |
| October 25, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 11, 2015 | OAI | Center for Devices and Radiological Health | Compliance: 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 991193 - 2016-10-25
- FDA Inspection 954714 - 2015-12-11
- FDA Inspection 756393 - 2011-12-19
- FDA Inspection 694698 - 2010-09-17
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