NEW YORK – In documents filed with the US Securities and Exchange Commission, Meridian Bioscience revealed that the US Food and Drug Administration conducted an inspection of its Magellan manufacturing facility in June.
The manufacturing facility is responsible for the firm's LeadCare products and the inspection followed a voluntary recall in May of certain lots of LeadCare II, LeadCare Plus, and LeadCare Ultra products.
According to the firm's 10-Q filing, the agency issued one Form 483 observation. A Form 483 is issued after an inspection when an investigator "has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts," according to the FDA website.
Observations are made when a food, drug, device, or cosmetic "has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health," the website explains.
Meridian did not disclose the specific observation.
The May recall, which is ongoing, was classified by the agency as a Class I recall, the most urgent of the three classes of recall. A Class I recall is defined as a "situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
Meridian noted in its SEC filing that it is working closely with the agency to execute the recall and Magellan, an independent business unit of the company, is responding to ongoing information requests related to the recall.
Magellan has previously faced regulatory action regarding its LeadCare business, including a warning letter issued by the FDA in 2017. The letter alleged Magellan marketed "significantly modified versions" of two blood-based lead testing systems without required clearance or approval. Magellan was also accused of failing to submit medical device reports to the FDA after it received customer complaints involving discrepancies in test results.
The 2017 warning letter was closed last week after the agency determined Magellan has addressed the issues. FDA added that future inspections and regulatory activities will "further assess the adequacy and sustainability of Magellan's corrections," Meridian noted in its 10-Q.
Meridian also said the recall's impact on the company's financial statements isn't believed to be material and no related costs are included in its most recent statements, namely its fiscal third quarter results released last week.
Meridian CEO Jack Kenny said on the company's earnings call that the recall, along with supply chain issues, resulted in approximately $1.5 million in back orders at the end of the quarter.