REMS audits are significantly different than”typical” site audits. Due to the complexity, requirements, and number of parties involved, REMS audits require an agile approach, which Compliance Architects® has shown continued success in delivering.
FDA conducts inspections to evaluate compliance with risk evaluation and mitigation strategies (REMS) requirements to ensure the drug’s health benefits outweigh the risks for patients. Inspections are prioritized using a risk-based approach.
The agency will take action if issues found during the REMS inspections are not promptly and adequately corrected. Failure to comply with REMS requirements may result in enforcement action such as product seizure, injunction or civil money penalties.
FDA also reviews REMS assessment reports to evaluate compliance with legal and regulatory requirements. The agency takes appropriate regulatory action for noncompliance, which may include warning letters or untitled letters, to address serious safety concerns and mitigate risks to patients.