FDA 483 - Clongen Laboratories LLC

An FDA inspection of Clongen Laboratories, LLC, a release testing facility in Gaithersburg, MD, revealed significant deficiencies across multiple areas of their operations. The firm was cited for inadequate quality oversight, a lack of written procedures for critical tasks, and failure to qualify and monitor equipment for its intended use. Additional observations included inadequate quality control documentation and practices, insufficient employee training, and the absence of a quality agreement with a third-party testing partner.