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Two Companies, One Owner; US FDA Sends Warning Letters To Same Address For Similar Issues

 
• By Brian Bossetta

Two Massachusetts-based infusion pump manufacturers with the same founder and CEO received warning letters from the US FDA for similar violations.

FDA Warning Stamp
• Source: Shutterstock

There’s nothing unusual about the US Food and Drug Administration sending warning letters to companies notifying them of potential violations that need to be corrected. But it’s another thing for the agency to send letters to two companies listed at the same address with the same owner for similar issues with similar products.

But that’s the case with InfuTronix and Zyno Medical, both of which recently received letters addressed to Chaoyung Lee, the CEO and founder of both companies, which are listed at...

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• By Brian Bossetta

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Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

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