06.11.15
Insulet Corp. has received a warning letter from the U.S. Food and Drug Administration (FDA) concerning some of the company’s insulin pumps. The letter followed an inspection by the FDA of its headquarters facility in Billerica, Mass. in March. At that time, the FDA had issued a Form 483 and the company filed its response letter in April. A Form 483 is usually issued at the end of an inspection when the investigator finds out violation of prescribed standards.
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, Insulet officials said in a regulatory filing. The lots were manufactured in mid-2013 and the first half of 2014.
Insulet reports that it does not expect the letter to have any adverse impact on its operations.
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, Insulet officials said in a regulatory filing. The lots were manufactured in mid-2013 and the first half of 2014.
Insulet reports that it does not expect the letter to have any adverse impact on its operations.