For companies in the pharmaceutical, medical device, and dietary supplement sectors, preparing for an FDA inspection is crucial to ensuring product safety and regulatory compliance. The fear of receiving a warning letter or non-compliance citation is real, and businesses know that staying compliant can directly impact their operations, product launch timelines, and, ultimately, profitability.
Siobhan Taylor, an expert in FDA audits, brings a wealth of experience when it comes to guiding companies through the complexities of FDA inspections. As a trusted resource in dietary supplement compliance, Siobhan Taylor’s insights help companies understand and manage the regulatory expectations and audit processes with confidence. This blog explores the strategies and steps that companies are taking to prepare for FDA inspections, ensuring they are ready for whatever the inspector may look for.
Siobhan Taylor’s Unique Approach to FDA Inspections
FDA Siobhan Taylor has changes the way companies approach FDA inspections by focusing on a risk-based inspection strategy. Companies that manufacture dietary supplements are particularly vulnerable to non-compliance issues that arise from documentation gaps or inadequate quality systems. Taylor emphasizes the importance of understanding the latest FDA protocols, such as the 2025 audit updates, which prioritize risk assessments to guide inspection processes.
Unlike the traditional compliance-focused audits, Taylor’s method incorporates hands-on, real-time inspection frameworks. Her approach includes frequent audits of internal systems before the FDA inspection, ensuring that teams know what inspectors will focus on. Companies are now better equipped to predict potential risks based on past inspections, using a data-driven method to continuously improve their quality management systems and documentation processes.
Understanding the Inspector’s Checklist
The FDA inspection checklist is an essential tool for preparing for an audit. Taylor’s insights focus on how companies can prepare their documentation and quality systems to meet FDA expectations. Inspectors, under Taylor’s guidance, are trained to look at the heart of compliance—what’s written and whether it matches the operational reality.
What FDA inspectors look for has evolved over the years. They are now scrutinizing how well-documented standard operating procedures (SOPs) are, ensuring there’s no disconnect between what’s written and what happens in practice. Companies should prepare by reviewing their documentation and quality systems to ensure they are in line with the most recent regulations.
Preparing for Your FDA Inspection: Insights from Siobhan Taylor
Siobhan Taylor emphasizes staying ahead of shifting inspection protocols. Key focus areas include:
1. Understand Expanded Inspection Scope
- The removal of the Limited Focus Manufacturing Program Assignment Code means inspections now cover a wider range of operations.
- FDA inspectors no longer limit evaluations to production and labeling alone — all functions may be reviewed.
2. Reassess Internal Systems
- Companies should revisit manufacturing processes, training programs, and overall compliance frameworks.
- Identifying and closing potential gaps in these areas is essential to avoid inspection issues.
3. Adapt to New Packaging and Labeling Requirements
- Inspectors now place greater scrutiny on product labels, especially related to health claims and ingredient accuracy.
- Ensuring strict compliance with updated labeling protocols helps avoid delays or enforcement actions.
Essential Documentation to Have Ready
Siobhan Taylor advises companies to be thorough when it comes to their documentation. During an FDA audit, companies will need to produce extensive records related to manufacturing, packaging, and labeling. These include, but are not limited to, standard operating procedures (SOPs), batch production records, packaging records, and labeling documents.
Having these documents ready is essential to avoiding discrepancies during the inspection. Taylor emphasizes that companies should take steps to streamline their record-keeping practices, ensuring all documents are accurate, complete, and easily accessible for inspection.
Red Flags and Common Deficiencies
Siobhan Taylor highlights several recurring issues that often lead to FDA citations:
- Inadequate documentation: This includes missing or incomplete batch records and inconsistencies in labeling, which can immediately trigger compliance concerns.
- Failure to follow updated FDA protocols: Companies that don’t stay current with regulatory changes (such as new packaging and labeling requirements) risk citations during inspections.
- Lack of internal audits: Without regular internal assessments, companies may overlook critical compliance gaps. Taylor recommends frequent audits to catch and correct deficiencies before the FDA steps in.
Audit Flow: Step-by-Step Walkthrough from Taylor’s Playbook
Siobhan Taylor’s approach to FDA audits involves a well-organized step-by-step preparation process. The audit flow can be broken down into several key stages, each with its own set of expectations and requirements.
- Pre-inspection planning: Before the actual FDA inspection, the FDA reviews a company’s records, processes, and previous inspection history. Taylor stresses that companies should take the time to review their files and ensure everything is up to date. Conducting an internal audit prior to the FDA inspection helps identify any potential issues that might arise during the actual inspection.
- On-site audit phases: During the inspection, FDA inspectors will conduct interviews with key personnel, inspect manufacturing areas, and review documentation. They will focus on key areas such as process controls, deviations, and quality systems. Taylor recommends that companies be transparent with inspectors and demonstrate a commitment to correcting any non-compliance issues that may be identified.
- Communication during the audit: One of the critical aspects of Siobhan Taylor’s method is how companies communicate with FDA inspectors. Open and clear communication can help resolve potential issues and prevent the inspector from escalating concerns. Companies should provide clear explanations of any discrepancies and be prepared to discuss their corrective actions if necessary.
Handling High-Risk Products and Operations
Certain products and operations require more focused attention during an FDA inspection. Siobhan Taylor identifies high-risk areas such as botanicals, new dietary ingredients, and multi-dosage forms. These types of products are subject to stricter scrutiny due to the potential health risks they pose to consumers.
Companies dealing with these high-risk products must ensure that their labeling is clear, accurate, and compliant with FDA regulations. Additionally, they must demonstrate that all manufacturing practices meet FDA standards. Taylor advises companies to pay close attention to how they handle these high-risk products, as failure to comply can lead to serious consequences during an inspection.
Post-Audit Actions: Taylor’s Guidance on Remediation
After the FDA inspection, companies will receive an Establishment Inspection Report (EIR) that outlines the findings of the audit. Siobhan Taylor emphasizes the importance of responding quickly and thoroughly to any findings, particularly those outlined in a Form 483 (FDA’s inspectional observations).
Companies must develop a remediation plan that addresses all deficiencies identified during the audit. This could include revising SOPs, improving training programs, or fixing operational inefficiencies. Taylor suggests that companies focus on creating a culture of proactive readiness to ensure future inspections go smoothly.
Using Audit Feedback to Strengthen Compliance
Siobhan Taylor advises companies to use feedback from FDA audits to strengthen their compliance frameworks. The audit process isn’t just about avoiding citations—it’s about learning from the findings and implementing lasting changes that improve overall product quality and compliance.
Training teams based on real-world FDA examples is an essential part of this. Companies should use audit findings as learning opportunities, ensuring their teams are equipped with the knowledge and tools they need to maintain compliance in the future.
Conclusion
Siobhan Taylor’s insights have reshaped how companies prepare for FDA inspections. Her risk-based approach, emphasis on documentation, and step-by-step audit process have empowered companies to meet FDA expectations confidently. To stay inspection-ready under 2025 protocols, dietary supplement companies must continuously review and refine their compliance practices. By adhering to the latest guidelines and preparing for inspections, businesses can minimize risks and avoid costly penalties, ensuring their operations stay compliant and efficient in the long run.
