FDA 483 - Clongen Laboratories LLC - June 17, 2025

Between June 16 and 17, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of Clongen Laboratories, LLC, a release testing facility located in Gaithersburg, Maryland. The inspection identified several critical deficiencies in the firm’s operational and quality control systems. Major violations included inadequate quality oversight, specifically the lack of an independent quality assurance unit and the failure to perform necessary internal audits or independent data reviews. The facility also lacked established written procedures for essential laboratory tasks such as sample receipt, equipment cleaning, and reagent management. Additionally, investigators observed the use of uncalibrated equipment and noted a lack of routine maintenance for critical systems. Documentation practices were found to be poor, with errors in test records and the use of unvalidated spreadsheets for data tracking. Furthermore, the firm failed to provide evidence of adequate staff training or maintain required quality agreements with partners. These observations were issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act. While the report does not constitute a final legal determination, Clongen Laboratories is required to review these findings and provide a detailed response to the FDA. This response must outline the corrective actions the company has implemented or plans to implement to ensure compliance with laboratory standards and regulatory requirements.