FDA WARNING_LETTER - Insulet Corporation - March 27, 2015

On June 5, 2015, the FDA issued a Warning Letter to Insulet Corporation following an inspection from March 11-27, 2015, which identified that their OmniPod Insulin Management System devices were adulterated. The inspection revealed non-conformity with Quality System regulation (21 CFR Part 820) regarding current good manufacturing practices.

Specifically, Insulet Corporation failed to establish and maintain procedures to control nonconforming product, as required by 21 CFR 820.90(a). The firm released five lots of EROS OmniPods (L40425, L40426, L40427, L40428, L40429) that failed release testing and fell below the firm's quality assurance final acceptance criteria, yet were released through a nonconformity review. An additional three lots within expiry were also identified as having failed final acceptance criteria but were released.

Insulet's April 16, 2015, response to the FDA Form 483 was deemed inadequate. While the FDA acknowledged the opening of CAPA-051 and revised acceptance procedures, the company was required to provide documentation of corrective actions, including verification of completion, and evidence of effectiveness, such as employee training on revised SOPs.

The FDA mandated prompt corrective action within fifteen business days to