On June 8, the U.S. Food and Drug Administration (FDA) sent Insulet a warning letter regarding their insulin pumps.
Violations Observed During FDA Inspection
According to MassDevice, the letter was sent after an FDA inspection of Insulet’s facility in Billerica, Massachusetts back in March. This inspection was labeled as a Form 483, meaning that the investigator found violations of some of the prescribed standards. The company filed a response letter in April.
The warning letter states that the release of some of the lots of the company’s Eros OmniPods did not meet the FDA’s final acceptance standards.
Insulet issued a statement claiming that they will take the matter seriously. The company has 15 days to respond to the letter and begin resolving the issue.
Insulet doesn’t believe that this warning will have any adverse impact on its operations.
About the Eros OmniPods
- The Eros OmniPod is a small, tubeless insulin pump which reads blood sugar levels and delivers insulin when necessary.
- The OmniPod also calculates the amount of insulin needed.
- The OmniPod includes a hand held PDM from which the operator man review readings.