Insulet Corp. said Wednesday it received a warning letter from the U.S. Food and Drug Administration over some of the company’s insulin pumps.
The company said the letter, which it received Monday, followed an inspection by the FDA of its facility in Billerica, Massachusetts, in March.
At that time, the FDA issued a Form 483 and the company filed its response letter in April.
A Form 483 usually is 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 said in a regulatory filing Wednesday.
The lots were manufactured in mid-2013 and the first half of 2014.
Insulet said it expects the letter will not have not any adverse impact on its operations.
The company’s shares closed at $30.25 on the Nasdaq on Wednesday.