483
Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC – FDA 483, Aug 24, 2012
Record Details
An FDA inspection of Merck Sharp & Dohme Corp. in Elkton, VA, an API and finished dosage pharmaceutical manufacturer, revealed two significant observations. The firm failed to thoroughly investigate unexplained discrepancies related to sterility assurance for Primaxin lots. Additionally, deficiencies were noted in aseptic processing areas concerning air supply and incomplete airflow pattern studies.
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ID · 6d963232-5fe6-44e9-8a6f-324e61081611
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