Granules Pharmaceuticals Inc.October 26, 2018

FDA 483 - Granules Pharmaceuticals Inc. - October 26, 2018

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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.

Company: Granules Pharmaceuticals Inc.
Inspection Date: October 26, 2018
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East II
People: Zhong Li
Amy Wang
Marcus A. Ray (Supervisory Consumer Safety Officer, China Office)

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ID · c226dccf-c3be-4513-9d02-7e866eb3fb84