Watson, FDA Reach Accord on Plant Flaws
Watson Pharmaceuticals Inc. said it has reached an agreement with the Food and Drug Administration on correcting quality flaws at a plant in Corona where the company makes generic drugs.
Watson will pay for an outside expert to conduct regular plant inspections, checking that equipment, record keeping and employee training meet federal standards, the FDA said.
The consent decree stems from problems the FDA cited at the plant from 1998 through 2001, Watson said.
The FDA cited flaws in Watson’s systems to validate the quality of its products and to check that equipment had been cleaned properly.
Watson shares rose 28 cents to $25.01 on Nasdaq.
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