FDA audits and inspections can be challenging and complex. Salvaxis helps businesses prepare for, manage, and respond to FDA inspections, minimizing the risk of compliance issues and enforcement actions.
Pre-FDA Inspection Assessments
Identifying compliance gaps before an FDA audit.
Mock FDA Audits
Simulating real inspections to uncover deficiencies and strengthen compliance.
FDA Form 483 & Warning Letter Responses
Assisting businesses in developing robust remediation plans.
Remediation Strategies
Implementing corrective actions and continuous improvement strategies.