News about GMP/cGMP

08.09.2017

CDRH Releases Eight Warning Letters for Device Manufacturers From Around The World

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) published a whole new round of warning letters. They are addressed to three manufacturers from the US and five in Brazil, the Netherlands, Germany, China and Bulgaria.

US Warning Letters were sent to:

  • SyncThink, who was warned for marketing an eye impairment device without being able to show any corresponding clearance or approval
  • Steiner Biotechnology, who received a warning letter for disturbing federal regulations in the process of clinical studies
  • Entellus Medical diverged from clinical trial protocols in a study.

Various countries:


Source:

CDRH: Warning Letters



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