In a signal of just how wrong things have gone at J&J, the company has now been slapped with a consent decree. Today's agreement signals that the FDA lacks any faith in J&J’s management to resolve the manufacturing woes and indicates the company requires outside oversight to correct the major manufacturing abuses. In essence, J&J gets to have the FDA hovering over its every move for the next five years. Frankly, even that amount of time may be insufficient to clean up the mess at J&J.
Today’s consent decree covers the three worst Johnson & Johnson facilities operating under the McNeil Consumer Healthcare Division: Fort Washington, Pennsylvania; Lancaster, Pennsylvania and Las Piedras, Puerto Rico.
It is important to understand that this announcement covers only the McNeil Division. Other J&J facilities with gross quality problems such as the San German, Puerto Rico facility could be added to a possible future consent decree. The manufacturing problems at J&J are much broader than the McNeil division, so J&J isn’t out of the woods yet.