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FDA Rebukes Four Companies, Including One Overseas, For Procedural Failures

 
• By Brian Bossetta

The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.

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In May, the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) sent warning letters to three device firms, following another issued in March but published alongside the May letters. The warnings related to violations of good manufacturing practice, QS regulations and requests for investigational device exemptions.

In its warning letter dated 9 May to Gary Gregory, president and CEO of Holliston, MA-based...

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