FDA 483 - Granules Pharmaceuticals Inc. - January 28, 2022

Granules Pharmaceuticals Inc, a drug manufacturer in Chantilly, VA, was cited with three observations during an FDA inspection. The firm failed to consistently follow established production and process control procedures, specifically regarding metal detection challenges. Additionally, the inspection revealed inadequate record-keeping for equipment cleaning and a lack of established and followed procedures for the cleaning and maintenance of equipment and the facility, leading to unsanitary conditions.