Watson Laboratories, Inc. Signs Consent Decree with FDA Requiring Corrective Actions be taken at Firm's Corona, California Manufacturing Plant

The Food and Drug Administration today announced that the drug manufacturing firm of Watson Laboratories, Inc., a Nevada corporation, has signed a consent decree requiring the firm to take all necessary corrective steps to ensure that its Corona, Calif., manufacturing plant is in strict compliance with FDA’s regulations governing good manufacturing practice. This decree requires the company to correct a longstanding series of problems with the Corona plant and its manufacturing procedures - problems which have resulted in drug products that were not in compliance with current good manufacturing practice.

During several previous inspections, FDA identified numerous, recurring and significant violations of current good manufacturing practice requirements at the Corona facility.

“Today’s action serves notice that FDA means business when it comes to upholding good manufacturing practices and other standards necessary for protecting the public,” said Dr. Lester M. Crawford, FDA’s Deputy Commissioner.

FDA’s current good manufacturing practice regulations help ensure that products are safe and work as they are intended.

The consent decree was submitted to the U.S. District Court for the Central District of California, and is subject to approval by the Court.

Under this decree the company must, among other things, retain (at its expense) a qualified expert to regularly conduct thorough inspections of the Corona plant and submit its findings to FDA. These inspections will carefully evaluate all vital aspects of the plant’s operations including its manufacturing equipment and systems, quality assurance and recordkeeping procedures, and employee training.

If FDA determines that the company is failing to comply with regulatory standards, the decree allows the agency to order the company to take a variety of actions to remedy the deficiencies. These actions could include ceasing manufacturing and related operations at this plant, and recalling affected products.

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