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FDA Inspection
•Insulet Corporation•October 31, 2008

Insulet Corporation – FDA Inspection, Oct 31, 2008

Record Details

This FDA Inspection record concerns Insulet Corporation, with an inspection on October 31, 2008, issued by the Center for Devices and Radiological Health, covering devices.

Company
Insulet Corporation
Inspection Date
October 31, 2008
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · eb41fea5-733c-4346-8b4b-2d3e3ec1ee39

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
546240
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

1
  1. 21 CFR 820.198(a)General

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Insulet Corporation

6
DateClassificationOfficeProject area
February 15, 2018NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
October 25, 2016VAICenter for Devices and Radiological HealthCompliance: Devices
December 11, 2015OAICenter for Devices and Radiological HealthCompliance: Devices
September 19, 2013VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
December 19, 2011VAICenter for Devices and Radiological HealthCompliance: Devices
View all 6 other inspections on the company page
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 848880 - 2013-09-19
  • FDA Inspection 756393 - 2011-12-19

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