483
Granules Pharmaceuticals Inc.Granules Pharmaceuticals Inc. – FDA 483, Oct 26, 2018
Record Details
Granules Pharmaceuticals Inc. in Chantilly, VA, a drug manufacturer, received two observations during an FDA inspection. The firm was cited for not having all manufacturing equipment for commercial products installed and qualified. Additionally, laboratory controls were found deficient due to the use of an analytical reagent with an unsupported expiration date for testing multiple drug products.
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ID · c226dccf-c3be-4513-9d02-7e866eb3fb84
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