Understanding FDA’s Post-Inspection Meetings | OAI vs. VAI Outcomes
OAI (Official Action Indicated) classification: the facility is deemed out of compliance with CGMP.
OAI regulatory meeting is conducted if FDA have already issued a warning letter. To DISCUSS THE ISSUES WITH THE FIRM BEFORE PURSUING LEGAL ACTION THROUGH THE DEPARTMENT OF JUSTICE. These meetings provide a deeper dive into technical matters that may require immediate attention, allowing for direct communication and feedback.
VAI (Voluntary Action Indicated) classification: facility may not be strictly out of compliance, still there are areas needing improvement.
VAI regulatory meetings provide an opportunity for the FDA to encourage voluntary compliance. AGENCY RECOMMENDS AREAS THE MANUFACTURER SHOULD EXAMINE, PROMOTING A COLLABORATIVE APPROACH TO MAINTAIN AND ENHANCE COMPLIANCE.
Benefits:
1) Foster dialogue between the FDA and drug manufacturers following compliance evaluations.
2) Clarify regulatory expectations, address deficiencies noted during inspections, and facilitate understanding of corrective actions needed to achieve compliance with Current Good Manufacturing Practices (CGMP).
3) Serves as an educational purpose.
Broader Perspectives:
“Educate while we regulate” rather than just providing information through formal letters—which can often lack context—regulatory meetings enable a two-way dialogue.
This interaction offers the FDA insight into a company’s perspective, fostering a collaborative spirit aimed at resolving issues before they escalate to formal compliance actions.
These meetings are valuable tools for reiterating regulatory requirements and addressing product-specific challenges, particularly in nuanced areas of regulation.
This targeted communication aims to ensure that company management fully comprehends and addresses the issues that could hinder compliance.
Read also:
- Inspection Vs Audit: A Comparison of Compliance Assessment Processes
- Pre-FDA Audit Inspection Day Checklist
Resource Person: Bharathi Kodali
