FDA 483 - Molecular Ms Diagnostics, LLC - April 16, 2024

Molecular Ms Diagnostics, LLC in Warwick, RI, a contract test laboratory, was inspected by the FDA and cited for two observations. The inspection revealed significant issues with data integrity due to inadequate computer system controls and deficiencies in equipment maintenance and requalification for temperature-controlling units. These findings indicate a moderate level of severity concerning quality control and data reliability.