Here’s our monthly summary of product recalls, import alerts, consent decrees, and corporate integrity agreements. A busy month!
by Barbara Unger, FDAzilla GMP Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence
A consent decree agreement is an agreement filed in the US courts formalizing a voluntary agreement between two parties. Here we will address consent decree agreements between FDA and several pharmaceutical companies based on repeated failures to adequately address CGMP deficiencies. It is not an action taken on the basis of a single form 483, or a single warning letter. Generally, a series of events play out over time when critical inspection observations are not addressed and are identified in subsequent inspections. Frequently one or more warning letters are involved. Consent decree agreements often include fines, with the option for additional financial penalties if conditions to which the firm agrees are not met. Often these firms are required to use a 3rd party consultants to perform lot release. Firms operating under a consent decree agreement have largely lost their independence in GMP activities. Unlike Corporate Integrity Agreement which have a defined duration, firms must petition to have the consent decree agreement condition rescinded.
“Forget about actual warning letters. The cost of us receiving a moderately bad 483 is roughly $250,000.”
I heard this from a reputable Head of Manufacturing of one of the largest biopharma companies in the world. While most pharma and med device companies seems to learn quickly from everyone else’s mistakes, companies still occasionally get a “moderately bad” 483. And then what happens after that? Continue reading