Surviving FDA Inspections: Proactive Preparation is Key

FDA inspections are a critical aspect of compliance for companies in FDA-regulated industry. Inspections help ensure that products are safe, effective, and meet the FDA's rigorous standards. However, the prospect of an FDA inspection can be daunting.

Gardner Law's experienced team includes former FDA investigator and compliance officer, Tim Philips, who worked at the Agency for over 30 years. He has a deep understanding of FDA regulations and enforcement practices. Tim presented on this topic and offers several tips for successful FDA inspections in this webinar.

Understanding the FDA Inspection Process

To alleviate anxiety and ensure a successful inspection, it is necessary to understand the FDA inspection process. The FDA conducts different types of inspections. They perform pre-approval and post-approval inspections to assess new products. They conduct “for-cause” inspections to review emerging product performance concerns. And finally, they do routine surveillance inspections to ensure ongoing compliance.

During an inspection, FDA investigators meticulously review a company's facilities, processes, and records to assess compliance with Current Good Manufacturing Practices (cGMPs), Medical Device Reporting, Corrections & Removals, and other requirements. Any non-compliance can result in Form 483 observations, Untitled Letters, Warning Letters, or even more severe regulatory actions. 

Proactive Steps to Prepare for an FDA Inspection

• Thorough Documentation: Maintaining meticulous records is essential. This includes standard operating procedures (SOPs), batch records, and documentation of any deviations or corrective actions.

• Employee Training: Ensuring that employees are well-trained in cGMPs and company-specific procedures is critical. Regular training sessions and competency assessments can help maintain compliance.

• Mock Inspections: Conducting internal mock inspections can help identify potential compliance gaps and allow for corrective action before an actual FDA inspection.

• Prompt Response to 483 Observations: If the FDA issues Form 483 observations, a timely and comprehensive response is crucial. Addressing the observations effectively can prevent further regulatory action.

How Gardner Law Can Help 

Navigating the complexities of FDA inspections requires specialized legal expertise. Gardner Law, an FDA law firm with extensive experience in regulatory law can provide invaluable assistance to companies preparing for and undergoing FDA inspections.

• Pre-Inspection Readiness: Gardner Law can help companies assess their compliance status, identify potential vulnerabilities, and develop strategies to address them proactively.

• During the Inspection: Gardner Law can provide on-site support during inspections, ensuring that companies understand their rights and obligations and interact effectively with FDA investigators.

• Post-Inspection Guidance: If the FDA issues Form 483 observations or other regulatory actions, Gardner Law can assist in developing and implementing corrective action plans and responding to the FDA.

"To survive an inspection, you need to be fully compliant with FDA laws and regulations. However, being compliant is not enough. You must also be ready to interact effectively with Agency representatives before, during, and after the inspection.” - Tim Philips

Expertise and Experience 

Gardner Law has successfully assisted numerous companies in navigating FDA inspections and achieving compliance. Contact Gardner Law today to ensure that your company is prepared for a successful inspection and to mitigate regulatory risk.