GXP Systems

Remediation Project - Consent Decree

Stericycle GxP were contacted by a market leading device manufacturer, based in the US, who had come to an arrangement with the FDA to operate under a partial consent decree.

The agreement came after FDA discovered that the organization had been deficient in their response to complaints from customers. Because of the nature of the goods manufactured, the organization were permitted to continue supplying products to their customers while correcting the necessary issues raised and ensuring that they would not become an issue again.

In this case study, you will discover the steps we took to ensure that the customers operations were improved to the necessary standards, enabling them to achieve compliance and exit the consent decree to the satisfaction of FDA.

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