Watson Pharmaceuticals Reports Progress On Quality Improvement Plan

Watson Pharmaceuticals Inc. (Corona, CA) has reported further details of its quality improvement plan being implemented at its Corona, CA facility. The plan addresses observations made by the Food and Drug Administration (FDA) in a January 1999 Warning Letter and a subsequent FDA inspection.

An aspect of Watson's plan that has been completed is its investigation of several uncontrolled documents found in its Quality Control and Analytical Services laboratories. In January 1999, Watson reported to the FDA their discovery of these documents, stopped the unauthorized use of these materials, and immediately instituted its own investigation.

Watson's investigation revealed no product safety issues. These findings were submitted in the company's final report to the FDA in March 1999. As part of its quality improvement plan, Watson has taken disciplinary action and has instituted additional training and supervision to better ensure compliance with its established policies and procedures.

Watson's quality improvement plan also specifically address Watson's investigative practices, laboratory controls, training, and documentation. The company has implemented and will continue to institute improvements in these areas at its Corona facility, and anticipates that these will be substantially completed within the next few months.

On a related matter, a May 11 letter from the FDA to Watson was released pursuant to a Freedom of Information Act request. In the letter, the FDA commented upon the company's previously submitted responses to the FDA's earlier observations. The May 11 letter requests additional responses on certain issues, seeks clarification on other matters, and highlights several areas of agreement between the FDA and Watson.

Watson Pharmaceuticals Inc. develops, manufactures, and sells proprietary and off-patent pharmaceutical products

For more information, call Watson Pharmaceuticals Inc. at 909-270-1400.