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Home » FDA WARNS DRUGMAKER FOR LABELING, RECORD VIOLATIONS
FDA WARNS DRUGMAKER FOR LABELING, RECORD VIOLATIONS
March 19, 2004
Contract manufacturer Andersen Pharmaceuticals has been warned by the FDA that labeling for one of its astringent products is not only out of compliance with the OTC monograph for the products, but that batch production records at the firm's Norwich, N.Y., facility are also deficient in four areas.