FDA Sends Warning Letter For Lack of Quality Agreement

The US Food and Drug Administration (FDA) sent a warning letter to FSC Laboratories for failure to establish a quality agreement with the manufacturer of its drug delivery device, according to a report by Outsourcing Pharma.

The letter, written in June, but published this week, found FSC's overall quality plan "adequate," but FDA raised several points for the company to examine.

Outsourcing Pharma reported quality agreements are important to FDA. Acting associate director Ann Meeker O'Connell told Outsourcing Pharma, "A sponsor has to indicate what specific responsibilities they're transferring... in writing."

FSC sent a response to the letter.

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Outsourcing Pharma: FSC sent FDA warning letter for lacking CMO quality agreement