FDAnews Drug Daily Bulletin
July 10, 2012 | Vol. 9 No. 134
FDA Flags API Contamination Concerns in FMC 483
Industrial chemical giant FMC received a Form 483 after FDA investigators found the company failed to minimize contamination risks at an alkali plant in Green River, Wyo., that makes pharmaceutical grade sodium bicarbonate and other active pharmaceutical ingredients (API). During a three-day inspection of the plant in January, officials with the agency’s Denver District office learned that the quality control unit’s responsibility for evaluating finished product subject to an investigation had not been outlined by FMC.
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