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BioWorld - Wednesday, April 8, 2026
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Home » FDA posts OUS device warnings as U.S. company receives second warning in three years
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FDA posts OUS device warnings as U.S. company receives second warning in three years

April 9, 2020
By Mark McCarty
The FDA’s device center has resumed a more normal pace of warning letter issuance in recent months, and the latest batch posted to the warning letter website features warning letters to one device maker in Europe and three firms in Asia. One U.S. firm, Steiner Biotechnology LLC, of Henderson, Nev., also received a warning, however, which is the second the company has received since June 2017.
Medical technology Regulatory FDA

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