Oct 23 (Reuters) - The U.S. Food and Drug Administration said on Monday it issued a warning letter to Meridian Bioscience Inc’s unit for several federal law violations after inspecting its facility that makes lead-testing devices.
The violations include selling significantly modified versions of two of its blood lead-testing systems without the FDA’s approval and failing to submit reports on the medical device after customer complaints.
In July, the U.S. regulator raised concerns about Meridian’s facility that makes the devices, nearly two months after the FDA warned that the tests may underestimate lead levels in blood.
Meridian has to notify the FDA before Nov. 10 about specific steps the company has taken to address these violations and to prevent them from recurring, the regulator said. (Reporting by Ankur Banerjee in Bengaluru; Editing by Arun Koyyur)