The U.S. Food and Drug Administration (FDA) has put a medical device manufacturer on notice for its failure to obtain proper approval for several versions of the company’s blood testing systems.
According to a warning letter sent by the FDA in October, the company, Magellan Diagnostics marketed “significantly modified” versions of two of its blood testing systems without the FDA’s required clearance or approval. The company also reportedly failed to submit to the FDA medical device reports after it became aware of customer complaints involving discrepancies in reported blood lead test results.
The warning letter stems from an investigation of Magellan’s facilities conducted by the FDA earlier this year in response to those consumer complaints. The FDA’s investigators reportedly observed evidence of the cited violations during their visit.
The company has until November 10th to notify the FDA of the specific steps it has taken to address the identified violations and to prevent them from reoccurring. Should the company fail to respond, it may be subject to additional action, including product seizures, injunctions and civil monetary penalties.