Warning Letters Special Report: The Decline And Fall Of Morton Grove Pharmaceuticals

It was bad enough that out-of-specification investigations were hugely inadequate, but the firm’s response to the FDA’s findings was even worse.

2022 Warning Letters Special Report
how morton grove wound up with a consent decree • Source: Shutterstock

US Food and Drug Administration warning letters are not always enough to compel improvements, and legal action may eventually follow, like it did for a manufacturing facility in Illinois that became a talking point for FDA compliance officials at recent conferences.

The denouement for the facility, and the string of FDA compliance actions and sometimes baffling company failure to respond, was...

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