What’s a warning letter, and how do I avoid getting one?
A Warning Letter is a formal letter from the FDA informing you about significant regulatory violations. The FDA can issue a Warning Letter at any time, but they’re most commonly sent after audits or inspections where significant violations are observed. If FDA observes some minor issues that it believes can be easily corrected, they’ll issue a Form 483. Warning Letters are more serious documents that require a thoughtful response in order to stop the FDA from pursuing more serious actions, including recalls and lawsuits. Warning Letters are also public - meaning anyone can read the list of violations FDA has found. Despite the title of these letters, they will place you in a list that is very difficult to get out of, and this standing will have an impact on your operations, revenues, and investor funding. This is another reason you want to avoid receiving a Warning Letter!
Most common reasons for Warning Letters
Since Warning Letters are public, the most common violations are searchable and knowing what these violations are can help you avoid regulatory violations. From 2017-2021, the most commonly cited violation for devices was failure to properly follow corrective and preventive action procedures. Specifically, these are violations of 21 CFR 820.100, which requires firms to establish procedures for analyzing and investigating non-conforming products, designing ways to fix them, and verifying or validating the fixes work. A common tendency is to sweep product issues under a sufficiently large rug, and in a regulated world, this would be a fatal error. Another common source of violations are from mishandling complaint files - these regulations are found in 21 CFR 820.198. Firms get issued Warning Letters when they do not properly document complaint investigations - even if complaints are unfounded. Oftentimes these citations are issued together - failure to properly investigate a complaint could lead to a failure to correct a non-conforming product. The critical first step is to designate first responders, reviewers and field action personnel to make sure the ol’ ‘not my job’ doesn’t set in. Less commonly seen citations include violations of Design Controls regulations (21 CFR 820.30), purchasing controls (21 CFR 820.50), and written MDR procedures (21 CFR 803.17).
Warning Letter Close-out
After you’ve received a Warning Letter from the FDA, you have 15 business days to respond. FDA expects your response to include specific corrective actions that can be verified, often with a specific timeline. In order to close out a Warning Letter, the FDA will verify that the corrective actions have actually been implemented.
We understand some of these regulatory issues can be intimidating - but Nemedio is here to help! Reach out below to see how we can help with Warning Letters or other regulatory issues.