Meridian Bioscience comments on FDA Warning Letter issued to subsidiary
Meridian Bioscience announced that the FDA has issued a Warning Letter related to matters at its Magellan Diagnostics subsidiary. In its July 27 press release, Meridian indicated that it expected Magellan would receive a Warning Letter based on the observations from the FDA's inspection, which was completed on June 29. Since the issuance of the FDA 483 Inspectional Observations at the conclusion of the inspection, Magellan has initiated prompt and comprehensive quality system remediation activities. Magellan will promptly submit a response to the Warning Letter for the Agency's consideration. Meridian Bioscience and Magellan reiterate their mutual commitment to strengthening Magellan's quality system and ensuring all aspects of the system are in full compliance. Both organizations take this very seriously. Magellan is addressing the observations noted in the Form FDA 483 and the Warning Letter with the highest sense of urgency.