Mock FDA Inspection & Compliance Risk Mitigation for Critical Site
The Challenge
With a major FDA inspection imminent, a top-5 pharmaceutical manufacturer engaged Light Pharma to conduct a rigorous mock inspection and develop a prioritized risk mitigation plan. The site had not been inspected in 4 years and had undergone significant changes.
Our Solution
Light Pharma's team of ex-FDA inspectors identified critical gaps and managed the remediation program through to completion, ensuring the site was inspection-ready within a compressed timeline.
Our Approach
Pre-inspection document review and gap analysis
On-site mock inspection by ex-FDA investigators
Risk prioritization based on comparable site histories
Project management of remediation activities through completion
Results
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