May 6, 2002–Corona, CA–Three years ago, pharmaceutical manufacturer Watson Laboratories, was issued a warning letter from the US Food and Drug Administration (FDA) regarding the company’s quality systems and cGMP (current good manufacturing practices) compliance, including deficiencies in its training, documentation and laboratory controls.
This past week the Watson signed a consent decree, which states that the company will maintain FDA guidelines for cGMPs at its Corona, CA facility.
Under the terms of the decree, Watson must hire a qualified expert to conduct annual inspections of its Corona plant and submit its findings to the FDA. The inspections will focus on the company’s manufacturing equipment and systems, quality assurance and record keeping procedures and employee training. Watson reported that it was not required to pay a fine, issue any drug recalls or shut down its manufacturing facility.
"By entering into this agreement with FDA, we affirm our confidence in the quality of our products and our commitment to continuing our quality initiatives," notes Allen Chao, Watson’s CEO. ":We worked closely and cooperatively with the FDA in reaching this agreement and look forward to a constructive relationship with them in the future."
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. However, if at anytime the FDA believes that the company is failing to comply with regulatory standards, the government agency may cease manufacturing and related operations at this plant, as well as recall affected products.