What to Do When the FDA Visits

When the U.S. Food and Drug Administration (FDA) comes knocking for an inspection, whether it’s a routine check or a for-cause visit, being prepared can make the difference between a smooth experience and costly disruptions. For companies in the pharmaceutical, biotech, and life sciences industries, FDA inspections are an integral part of ensuring compliance with regulations aimed at safeguarding public health. This blog will guide you through the steps to take when an FDA inspection is imminent, how to navigate the visit itself, and ways DSI can support you through the process.

Understanding Why the FDA Visits

FDA inspections can occur for several reasons, and understanding why they are happening can help you tailor your response. Inspections generally fall into four categories:

1. Routine Inspections: These occur periodically and include pre-approval inspections (PAIs) for new drug applications (NDAs) or biologics license applications (BLAs).
2. For-Cause Inspections: These are triggered by safety issues, complaints, or concerns, such as product recalls or adverse event reports.
3. Post-Market Surveillance: Even after approval, the FDA may visit to ensure that your operations remain compliant with manufacturing and safety standards.
4. Follow-Up Inspections: If a company has previously received warning letters or inspection observations (483 forms), the FDA will return to verify that corrective actions have been taken.

Key Steps to Take When the FDA Visits

1. Preparation is Crucial

An FDA visit may be unannounced, so companies must always be ready. You can’t predict when an inspector will show up, but you can ensure that your team is prepared.

• Conduct Internal Audits: Regular internal audits and mock inspections can simulate real FDA visits, helping your team practice responses and familiarize themselves with compliance requirements.
• Review SOPs and Documentation: Ensure your Standard Operating Procedures (SOPs) are up to date, and all compliance records are accurate and easily accessible.
• Train Your Staff: Every employee should know their role in the inspection process, especially those interacting with inspectors.

2. Organized Documentation

FDA inspectors will review extensive documentation during their visit, from manufacturing records to validation protocols. Having these documents readily available ensures a smooth process.

• Organize Records: Ensure all necessary documents, such as quality control records and Current Good Manufacturing Practice (CGMP) compliance data, are organized and readily accessible.
• Accuracy and Completeness: Double-check that all documents are complete and up to date to avoid unnecessary scrutiny during the inspection.

3. Engaging with Inspectors

Your team’s interactions with FDA inspectors are critical in shaping the outcome of the inspection. Be transparent, cooperative, and professional in all dealings.

• Designate Spokespeople: Assign a small, trained team to handle communications with the FDA. These individuals should know how to answer questions clearly without volunteering unnecessary information.
• Professional Conduct: Keep responses factual and direct. Avoid providing more information than asked, as this can lead to additional scrutiny.

4. Facility Readiness

The FDA will inspect various aspects of your facility to ensure it meets regulatory standards. Make sure your operation is always in compliance.

• Inspect Cleanliness and Equipment Maintenance: Ensure your facility is clean, your equipment is properly maintained, and employee training records are up to date.
• Process and Compliance: Review CGMP requirements and ensure your manufacturing processes meet FDA standards.

5. Responding to Inspection Findings

If the FDA issues a Form 483, detailing areas of non-compliance, the company must respond promptly.

• Develop a Corrective Action Plan (CAPA): Ensure that all observed issues are addressed in your response to the FDA. Include detailed plans and timelines for resolving the problems.
• Follow Up: After implementing corrective actions, provide documentation to the FDA that demonstrates compliance and resolves any flagged issues.

How DS InPharmatics Can Help

Navigating an FDA inspection can be overwhelming, but with the right partner, you can ensure that your company is ready, compliant, and responsive. Here’s how DS InPharmatics (DSI) supports companies during FDA visits:

1. Inspection Readiness Services

• Internal Audits and Mock Inspections: DSI offers expert-led internal audits and mock inspections that simulate real FDA visits, helping your company identify gaps and vulnerabilities.
• Documentation Assistance: DSI’s team helps organize and review your documentation, ensuring it is inspection-ready and compliant with FDA expectations.

2. Regulatory Strategy and Consulting

• Regulatory Submissions: DSI specializes in preparing FDA-compliant submissions for NDAs, BLAs, and Investigational New Drug (IND) applications, minimizing the risk of inspection-triggering delays or rejections.
• CGMP Compliance Consulting: Our team can assess and optimize your manufacturing processes to meet CGMP standards, a frequent focus of FDA inspections.

3. Handling FDA 483s and Warning Letters

• Corrective Action Support: If you receive a Form 483, DSI assists with developing a robust Corrective and Preventive Action (CAPA) plan to ensure a swift and effective response.
• Post-Inspection Remediation: DSI provides post-inspection follow-up services to ensure that any identified issues are resolved promptly and compliance is maintained.

Closing Thoughts

FDA inspections are a fact of life in the pharmaceutical and biotech industries, but with proper preparation and support, they don’t have to be a source of stress. By implementing robust compliance measures and partnering with DS InPharmatics, your company can face FDA visits confidently and successfully.

Contact DSI today to learn how we can help your company prepare for FDA inspections and stay compliant with regulatory requirements.