Granules Pharmaceuticals Inc.January 17, 2020

FDA 483 - Granules Pharmaceuticals Inc. - January 17, 2020

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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.

Company: Granules Pharmaceuticals Inc.
Inspection Date: January 17, 2020
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East II
Person: Sena G. Dissmeyer

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ID · 9fe1058e-33b6-49d9-9426-06f3421359e1