FDA 483 - Clongen Laboratories LLC

Clongen Laboratories, LLC, a release testing facility in Gaithersburg, MD, received a Form 483 with six observations. The inspection revealed significant deficiencies in quality oversight, lack of written procedures for critical tasks, unqualified and unmonitored equipment, and inadequate quality control documentation and practices. Additionally, issues with employee training and the absence of a quality agreement for mycoplasma release testing were noted.