FDA Warning Letters 2025 Recap: Key Lessons for 2026 Compliance

2025 Warning Letter Overview

FDA warning letters are official notices that a company has significantly violated FDA regulations. They are issued after an inspection or investigation reveals violations serious enough to warrant regulatory action. Warning letters are public documents posted on FDA's website and can severely impact a company's reputation, import ability, and business relationships.

In fiscal year 2025 (October 2024 through September 2025), FDA demonstrated a clear escalation in enforcement across multiple product categories. The agency's budget increases and workforce expansion under FSMA and MoCRA funding translated directly into more inspections and more warning letters.

This is not a temporary trend. FDA Commissioner testimony before Congress in 2025 emphasized that enforcement resources would continue to grow, particularly for food safety, cosmetics under MoCRA, and drug manufacturing quality.

CDER: 50% Increase in Warning Letters

The Center for Drug Evaluation and Research (CDER) issued approximately 50% more warning letters in FY2025 compared to FY2024, according to analysis by the Regulatory Affairs Professionals Society (RAPS, published December 2024). Key observations:

The surge in CDER warning letters reflects FDA's post-pandemic return to full inspection capacity. During 2020–2022, domestic and foreign inspections were significantly curtailed. The backlog of deferred inspections combined with new enforcement priorities created the conditions for the FY2025 spike.

Top Violation Categories

Across all FDA centers, the most frequently cited violations in FY2025 warning letters fell into these categories:

Food/Cosmetics Inspection Surge

Reed Smith LLP reported that FDA conducted approximately 1,540 additional domestic food facility inspections in FY2025 compared to the prior year. This increase was funded by FSMA implementation appropriations and reflected FDA's renewed focus on preventive controls compliance.

For cosmetics, FDA began its first systematic inspection program under MoCRA. While the number of cosmetics inspections was modest compared to food, the impact was significant because many cosmetics companies had never been inspected by FDA before. Common findings included:

• No facility registration: Companies that had not yet registered their cosmetics facilities under MoCRA Section 3504
• Missing product listings: Products manufactured or distributed without required SPL listing submissions
• No adverse event reporting system: Companies lacking a process to collect and report serious adverse events within the 15-business-day MoCRA requirement
• Inadequate safety substantiation: Insufficient evidence supporting the safety of marketed cosmetics products

Import Enforcement Trends

Import enforcement remained a high priority for FDA in FY2025. Key trends affecting foreign manufacturers and US importers:

• Import alerts: FDA maintained over 70 active import alerts covering specific products, countries, and manufacturers. Detention without physical examination (DWPE) continued to be the primary enforcement tool.
• FSVP inspections: Foreign Supplier Verification Program inspections of US importers continued at elevated levels. The most common finding was failure to have an adequate FSVP for each food imported (21 CFR Part 1, Subpart L).
• Prior Notice refusals: Incomplete or inaccurate Prior Notice filings remained a top reason for food import refusals at the border.
• US Agent compliance: FDA increased scrutiny of US Agent designations, particularly for facilities where the designated agent was unreachable or had resigned.

Foreign manufacturers exporting to the US should ensure their registration is current, their US Agent is responsive, and their US importers have robust FSVP programs in place.

Lessons for 2026 Compliance

Based on FY2025 enforcement patterns, here are the key lessons for companies planning their 2026 compliance strategy:

1. Registration is table stakes: Unregistered facilities are the easiest enforcement targets. Ensure all facilities are registered and listings are current.
2. cGMP compliance cannot be deferred: The 50% increase in CDER warning letters signals that FDA is not accepting pandemic-era excuses for cGMP gaps.
3. MoCRA enforcement is real: Companies that assumed cosmetics regulation would be loosely enforced should adjust their expectations. FDA is staffing up for MoCRA inspections.
4. Documentation matters: In nearly every warning letter, FDA cited inadequate or missing documentation. Maintain complete records and make them readily available for inspection.
5. Adverse event systems must be functional: Simply having a policy is not enough. Your adverse event reporting system must be tested, staffed, and capable of meeting regulatory timeframes.
6. Invest in prevention: The cost of a warning letter response (legal fees, remediation, lost business) far exceeds the cost of proactive compliance programs.

How to Stay Ahead

Proactive compliance is the best defense against FDA enforcement. Here is how to position your company for success in 2026:

• Audit your registrations: Verify all facility registrations and product listings are current across food, drugs, devices, and cosmetics. Use our renewal checker tool to confirm status.
• Conduct a mock inspection: Walk through your facility with a critical eye, using FDA's own inspection checklists as a guide. See our inspection preparation guide.
• Review labeling compliance: Ensure all product labels meet current FDA requirements for your product category.
• Test your adverse event system: Run a simulated adverse event through your reporting system to verify it works within required timeframes.
• Monitor FDA enforcement: Track import alerts, warning letters, and recalls relevant to your product category using Assurentry's warning letter search tool.