483
PPD Development, L.P.FDA 483 - PPD Development, L.P. - May 14, 2018
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An FDA inspection of PPD Laboratories, GMP Lab in Middleton, WI, a biopharmaceuticals analytical facility, revealed a significant quality control issue. The firm used an expired reference standard in multiple studies without providing any justification for its continued use. This indicates a potential lapse in quality control and adherence to good manufacturing practices.
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ID · 378f5be0-1030-40fb-b0fd-ea96e1302769