FDA 483 - Granules Pharmaceuticals Inc. - December 08, 2017

An FDA inspection of Granules Pharmaceuticals Inc., a drug product manufacturer in Chantilly, VA, revealed deficiencies in its quality control unit. The firm failed to properly document corrective and preventative actions (CAPA) and did not adhere to its own procedures for the timely review of Standard Operating Procedures (SOPs). These findings indicate a lack of adherence to established quality system requirements.