Watson Revises Quality Control
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Watson Pharmaceuticals Inc., one of the biggest makers of generic drugs, on Monday replaced management in charge of quality control at two facilities after warnings from the Food and Drug Administration.
The changes came after Watson received a warning letter last month from the FDA following a January inspection of its manufacturing plant in Miami. A warning letter was also issued after the agency inspected its Corona facility in January. Both FDA letters cited problems with training and documentation.
“We believe these reorganizations will better coordinate and focus our resources in these important areas,” said Allen Chao, Watson’s chief executive.
Corona-based Watson announced the management changes and the April FDA letter in a news release after the close of trading Friday. On Monday, its shares rose $2.75 to close at $43.25 on the New York Stock Exchange. Its shares have fallen about 30% this year.
The FDA sends hundreds of warning letters each year, and only a small minority result in any significant agency action. Still, the letters can be the last notice before the FDA takes steps such as holding up approvals of new products or pursuing civil fines.
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