Cormica's US Lab Successfully Completes Unannounced FDA cGMP Inspection with No Findings

Cormica is pleased to announce that its analytical testing facility in Cherry Hill, New Jersey has successfully completed an unannounced U.S. Food and Drug Administration (FDA) inspection for current Good Manufacturing Practice (cGMP) compliance. The inspection, which took place over two days, concluded with a No Action Indicated (NAI) outcome and no issuance of a Form 483.

This result reflects an outstanding level of compliance and reinforces the strength of our quality systems. It also highlights the professionalism and preparedness of the team.

An NAI classification is the most favourable outcome possible from an FDA inspection, indicating that no significant observations or deviations from regulatory expectations were identified. Achieving this during an unannounced inspection demonstrates the continuous state of readiness and operational excellence upheld at Cormica’s US facilities.

Cormica provides analytical testing services for pharmaceuticals, medical devices and combination products, supporting customers from early-stage development through to post-market surveillance. Our Analytical Chemistry capabilities include method development and validation, quality control, stability testing, extractables and leachables, elemental impurity analysis and more.

This successful FDA outcome not only affirms our regulatory compliance but also supports the trust that our partners, regulators, and stakeholders place in Cormica’s operations. We continue to invest in our people, systems and facilities to ensure we meet the highest standards of quality and service.

For more information about our analytical services or to speak with our team, please contact sales@cormica.com.