FDA 483 - Granules Pharmaceuticals Inc. - August 21, 2019

Granules Pharmaceuticals Inc. in Chantilly, VA, was issued a Form 483 following an inspection from August 7-21, 2019. The inspection revealed that incoming components were not stored under quarantine until released, and the firm failed to follow its written procedures for the storage of components. These issues indicate deficiencies in material control and adherence to established quality procedures.