Insulet received warning letter from FDA
The issue noted in the warning letter relates to the company’s release of certain lots of EROS OmniPods that did not conform to final acceptance criteria. The lots identified in the warning letter were manufactured in mid-2013 and the first half of 2014.
On April 16, 2015, the company submitted a response letter to the FDA, received on March 27, 2015. In the June 2015 warning letter, the FDA stated that the corrective action plans implemented by the company as referenced in its April response letter should address this issue.
The FDA requests a description of the corrective actions and verification when complete, as well as information to demonstrate that the corrective actions have been effective. Insulet is required to respond within 15 days.
The company intends to respond to the issue raised in the FDA’s letter within 15 days and is committed to resolving this issue with the FDA. ■