Case Study

Expanding Medical Device Supplier Avoids FDA Penalty

Expanding Medical Device Supplier Avoids FDA Penalty

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The solution The supplier turned to our medical device specialists to perform a compliance assessment of the facility’s operation and identify elements that threatened noncompliance. Our medical device experts quickly provided a report that identified all elements that were noncompliant or could have been noncompliant in an imminent FDA inspection. The team provided a remediation plan to identify these resources and apply them against a tim

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