Amid evolving regulatory landscapes, FDA inspections continue, and enforcement remains a top priority for the agency. In a recent FDA inspection trends webinar, Nixon Peabody partner Hannah Bornstein was joined by Teresa Gorecki and Ricki Chase of Compliance Architects to discuss current FDA enforcement priorities. They shared practical guidance on how companies can prepare for and manage inspections, as well as respond effectively to any FDA Form 483s or warning letters issued following an inspection.
The session was designed for companies subject to FDA inspection authority, including pharmaceutical, medical device, food, and cosmetics companies, as well as entities involved in clinical trial research.
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The following highlights capture the core points from our conversation.
FDA enforcement priorities and regulatory updates
Several developments are shaping the FDA’s enforcement landscape, including:
- False Claims Act collaboration: The DOJ and HHS have formed a False Claims Act Working Group to combat healthcare fraud. HHS is expected to refer potential False Claims Act violations to DOJ, reflecting the Working Group’s priorities. Working Group priority areas include what the DOJ has described as “materially defective medical devices that impact patient safety,” kickbacks, and medical products pricing.
- Advertising crackdown: On September 9, 2025, the FDA announced an increased “Crackdown on Deceptive Drug Advertising,” focusing on misleading direct-to-consumer advertising, claims substantiation, and influencer partnerships.
- LDTs in flux: After years of regulatory ambiguity, the FDA announced in August 2025 that it is rescinding its final rule classifying laboratory-developed tests (LDTs) as medical devices. This remains a complex and evolving area.
- QMSR implementation: The Quality Management System Regulation (QMSR), intended to harmonize with ISO 13485, goes into effect in February 2026. Companies subject to 21 CFR Part 820 must prepare for new inspection techniques and ensure compliance with ISO 14971 for risk management.
- Modernization of Cosmetic Regulations Act (MoCRA) and cosmetics GMPs: The FDA must finalize its good manufacturing practices (GMP) rule for cosmetics by December 29, 2025. Companies in this space should monitor developments closely.
FDA inspection readiness: Preparation strategies
As Teresa Gorecki noted during the webinar, “FDA inspections are like a first date.” From the moment the inspector arrives, your facility, documentation, and staff must be ready to make a strong impression.
Key preparation steps include:
- Training front-line staff: Receptionists and security personnel—the individuals inspectors are most likely to encounter first when arriving at a company—must know how to respond when FDA (or any other government agent) arrives.
- Designating experienced leads: The inspection lead should understand the FDA’s expectations and effectively coordinate with subject matter experts (SMEs) throughout the inspection.
- Maintaining clean, organized facilities: First impressions matter. Facility readiness reflects your overall compliance culture.
- Documenting systems and training SMEs: Subject matter experts must be able to explain processes and data clearly. Documentation should be well-written and easy to access.
- Using scribes and keeping records: Accurate daily inspection notes are essential for developing post-inspection responses and mitigating enforcement risk.
- Ensuring oversight of your CDMO or CRO: Robust quality agreements with contract development and manufacturing organizations (CDMOs) and contract research organizations (CROs) are critical to ensure you have sufficient oversight and monitoring when any third party contracted to conduct research, testing, or manufacturing work is inspected by the FDA.
Responding to FDA Form 483 and warning letters
An FDA Form 483 is not just a list of observations—it signals that the FDA views a facility as having systemic issues in the areas identified. Companies have 15 business days to respond, and that response must be:
- Timely and thorough: Consider where to acknowledge gaps, outline interim controls, and commit to corrective actions with clear timelines.
- Systemic and strategic: FDA expects a holistic review of the quality system issues identified, not just fixes limited to specific examples.
- Supported by leadership: Quality issues are not solely the responsibility of the QA team. Cross-functional collaboration is essential to secure resources and drive change.
When a warning letter is issued, the stakes are even higher. A warning letter signals that the FDA is considering further legal action. Companies must:
- Engage experienced counsel, SMEs, and/or consultants: Legal and regulatory professionals help interpret FDA language and guide remediation efforts.
- Wholistically address quality systems issues raised: Responses must go beyond the cited examples in the observations and demonstrate systemic compliance.
- Avoid minimizing the issue: A warning letter is a serious matter. The FDA utilizes warning letters (in part) to give companies time to come into voluntary compliance with FDA regulations. Ultimately, the FDA controls market access, and resolving the letter is critical to long-term business continuity.
Staying prepared for FDA inspections and enforcement
FDA inspections are complex, high-stakes events that require preparation, transparency, and strategic response. Whether you're a startup navigating your first inspection or a global manufacturer managing multiple sites, the principles remain the same: be proactive, be thorough, and be ready.
Whether you’re preparing for an inspection or responding to enforcement actions, feel free to reach out to the presenters—Hannah, Teresa, or Ricki—for insights.
