483
Granules Pharmaceuticals Inc.Granules Pharmaceuticals Inc. – FDA 483, Jan 17, 2020
Record Details
An FDA inspection of Granules Pharmaceuticals Inc. in Chantilly, VA, revealed three significant observations related to manufacturing controls. The firm was cited for issues concerning equipment design and qualification, a lack of adequate written procedures for production and process controls, and incomplete master production and control records. One observation regarding equipment was a repeat finding from a previous inspection.
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ID · 9fe1058e-33b6-49d9-9426-06f3421359e1
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