The Food and Drug Administration issued a warning letter to Alere Inc saying the diagnostic device maker's response to the health regulator's earlier observations on manufacturing processes for the company's Triage products was not adequate.
The FDA said in its letter on Monday that Alere will need to complete a revalidation of the entire assembly process of adding, dispensing and packaging the Triage products at its San Diego, California facility.
The company recalled 104 lots of its Triage cardiology products from the facility in May after the FDA said it did not satisfy a particular quality control method as prescribed by the regulator.
"While the FDA warning letter is not material news by itself, Alere's level of transparency and execution has been frustrating," Goldman Sachs analyst Isaac Ro said in a note to clients.
In Monday's letter, the health regulator also warned Alere that a failure to promptly correct the violations may result in regulatory actions.
Alere has 15 business days to correct the violations and notify the regulator on steps the company will take to avoid these violations.
Triage products accounted for 9 percent of the company's sales of $463.4 million for the quarter ended June 30.
The products help in the diagnosis of critical diseases and health conditions, including heart failure and heart attacks.
Alere's shares were down about 2 percent at $19.50 on Wednesday morning on the New York Stock Exchange.
(Reporting By Adithya Venkatesan; Editing by Sriraj Kalluvila)
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