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Insulet Corp Receives FDA Warning Letter for Insulin Pumps

Brooke Shroyer1 year ago

On Wednesday, Insulet shared that the U.S. Food and Drug Administration filed a warning letter to the corporation in regards to the safety of their insulin pumps.

Details fo the FDA Warning

Insulet Corporation is an insulin management company that provides insulin pumps for people with diabetes.  One of their popular products, the EROS OmniPod, is a personal diabetes manager in the form of an insulin pump that wirelessly programs your individualized insulin delivery.

According to Medscape, Insulet received the letter on Monday, which was followed by an FDA inspection on the company’s faculty in Billerica, MA.  This letter filed by the FDA was a Form 483.  A Form 483 is a warning letter released after an inspection where evidence of violations on safety standards have been found.

More About the Form 483

The FDA sent out a Form 483 letter to Insulet Corp and the company issued its response in April.  The letter included a finding on Insulet’s EROS OmniPods that did not comply with the FDA’s safety requirements and criteria. 

The products were manufactured in mid-2013 and halfway through 2014.  Insulet Corp claimed that the FDA warning letter should not influence any setbacks on the company’s operations.

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