FDA notifies 14 international medical device companies about regulatory violations

Mackenzie Bean (Twitter) -

The Food and Drug Administration sent warning letters to 14 international medical device manufacturers, citing various regulatory concerns and issues.

The most common issues cited by the FDA were:

  • Failure to establish and maintain adequate procedures for implementing corrective and preventative action — 11 citations

  • Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit — 8 complaints

  • Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements — 7 complaints

  • Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements — 6 complaints

Here are the 14 device manufacturers that received warning letters:

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