USFDA issues warning letter to Insulet Corp

USFDA (Food and Drug Administration) has issued Insulet Corp Form 483 over some insulin pumps. Insulet official said “The letter relates to the release of certain lots of the company's EROS OmniPods that did not conform to the FDA's final acceptance criteria”. The lots were manufactured in mid-2013 and the first half of 2014. A Form 483 is usually issued at the end of an inspection when the investigator finds out violation of prescribed standards. The company said the letter, which it received on 8th June followed an inspection by the FDA of its facility in Billerica, Massachusetts in March. Insulet said it expects the letter will not have any adverse impact on its operations. Insulet’s OmniPod System is a completely unique approach offering all the benefits of insulin pump therapy, with none of issues.