The paperwork problem: How many FDA warning letters actually cite document failures
When people take a medication, they trust that it contains the right amount of active ingredient and is free of harmful contamination. Manufacturing and test records help verify that trust. When those records are missing or incomplete, it's harder to establish whether a drug meets quality standards.
In 2025, the U.S. Food and Drug Administration issued 303 warning letters to drug and biologics firms. That’s a significant increase of 59% from the year before. Documentation, recordkeeping, and data integrity issues show up in many of these letters.
To see how often these problems were cited, Kivo dug into public FDA postings from 2021 to 2026. The sources included the FDA's annual compliance report, warning letter database, electronic records, and inspection observations.
In every year of this period, at least 94% of the warning letters Kivo classified cited a documentation, recordkeeping, or data integrity problem in some form. The share classified as having these issues as the primary reason for the letter ranged from 15% to 53%, depending on the year.
A documentation problem doesn't automatically mean a medication is unsafe, but unreliable records can leave gaps in the evidence used to show that the medicines people depend on were properly made and tested.
How the count works
The methodology behind the count starts with the FDA’s public Warning Letters database. To narrow in on human drug and biologics firms, the count was limited to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Data was pulled at the end of September, so it reflects data through the end of Q3.
The 303 letters issued in 2025 include many that have no inspection data. Less than half included that. Every share in this count is a percentage of the letters that Kivo classified rather than the FDA fiscal year totals.
Each letter was read against the federal regulation sections that it cites and was coded in one of four ways. "Primary" refers to a situation where a documentation, recordkeeping, or data integrity failure was cited as the main cause for the letter. "Contributing" means it reinforced other violations. "Incidental" indicates a side finding to the letter that is driven by something else. "None" means there wasn’t a documentation-related citation at all.
What the count shows
Based on the FDA Warning Letters database and their broader data dashboard, the classifications for the nearly five-year period are:
In 2021, just 15% of letters cited documentation as the primary cause. That continued to rise until it peaked in 2024 at 53%. The rate fell to a year-over-year stable 37% in 2025 and 2026.
Incidental findings started at a high 84% in 2021 and fell to a low of 43% in 2024 before stabilizing at 59% in the last two years. "Contributing" and "none" both stayed relatively the same during the five years.
What documentation failure means
The count clearly depends on the definition of “documentation failure.” The easiest way to define it is to rely on the FDA itself.
In its Data Integrity and Compliance With Drug CGMP document, data integrity is defined as the completeness, consistency, and accuracy of data. It must also be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.
That’s a broad scope. Documentation failure, as a result, can cover a wide range of problems. Anything from missing audit trails, shared credentials, backdated entries, or inadequate data can be a cause.
This definition also covers procedural rules that are meant to govern records under 21 CFR Part 211 and Part 11. Under these definitions, documentation failure can also be cited without alleging falsifications, which is why "incidental" appears as such a large category.
The inspection signal
The failure letter is the result, but the inspector’s list is where the true information lies. Leveraging the FDA’s Inspection Observations annual datasets from 2021-2026, it’s easy to see where and why pressure builds. The same three causes have held the top spots over the last five years in the Drugs and Biologics database:
Quality unit written procedure and record review and investigations have swapped places over the five years, but written production procedure has stayed constant in the third position.
Five of the 10 most-cited provisions lean on procedures or records rules by name alone, providing context on why documentation appears as an issue in almost every letter from the FDA.
What leaders can do
The data points to execution more than documentation. To ensure you stay in compliance and avoid getting a letter, there are three steps leaders can take.
- Audit your practice against procedure: The top Form 483 citation is failing to follow written quality unit procedures, so ensure every step of your process is in compliance.
- Treat record reviews as a control step: Given that record review and investigations is cited as the second provision leading to failure, it’s best to take a close look. FDA guidance expects all audit trails to be reviewed just as often as the records they support. As a rule of thumb, name who reviews what, when, and how often.
- Prepare the 483 response ahead of time: Based on FDA Form 483 response guidance from March, you will have 15 business days to provide a consolidated draft signed by executive management. Being on top of this step can ensure the FDA stays on top of your review.
Keep your organization in compliance
Paperwork was the primary finding in many FDA warning letters over the period this analysis measured, but the data shows that it may not be the main cause for long.
Given that documentation failure arises in nearly every letter and Form 483 citations have barely changed during this time, your organization is capable of getting ahead of any problem. Audit your practices, encourage broader record reviews, and be ready to respond if the FDA issues a failure to proactively tackle the issue.
What consumers can do
Patients can stay informed about their medications and ask for help when concerns arise.
- Check recall notices: The FDA's drug recall resources can help consumers identify affected products. They should compare the lot number in the notice to their medication's packaging, or ask their pharmacist to check.
- Follow medication instructions: If a medication is recalled, consumers should follow the recall notice and contact their pharmacist or prescriber for guidance on what to do next.
- Speak up about suspected problems: Consumers should tell their pharmacist or prescriber about unexpected side effects or concerns about how the medicine is working.
Patients can also report suspected quality problems, serious side effects, or a medicine's failure to work through the FDA's MedWatch program.
This story was produced by Kivo and reviewed and distributed by Stacker.