FDA Warning Letters are an immediate call to action for an FDA-regulated company. Then can end up costing a company thousands of dollars, and result in a negative reputation with customers and other companies. If the actions listed in the Warning Letter are not diligently corrected, they can also lead to even greater fines and a company potentially being shut down.
Because Warning Letters are so important, it’s necessary to understand what types of companies receive FDA Warning Letters, the severity, and how a Warning Letter can impact your company.
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What is an FDA Warning Letter?
An FDA Warning Letter is a notification from the FDA to a company indicating that the FDA has found that the company significantly violated FDA regulations. It can be the result of marketing material or an audit (routine or as the result of a complaint).
A Warning Letter can either be an escalation of a 483 notification or given directly to a company if the violations are severe enough to warrant immediate action.
Warning Letters are typically delivered by hand from the FDA to highlight the severity of the situation and ensure a prompt response is possible. They will set a deadline for when corrective actions need to be completed, which is typically 15 days from receipt.
The intention of a Warning Letter is to give a company a chance to voluntarily correct violations before they are subject to any enforcement actions. For that reason, the FDA does not consider Warning Letters final actions. Any issues listed in a Warning Letter should be corrected as soon as possible so that there are no further consequences for the company.
After all of the issues are corrected and there is proper follow-up with the FDA, the FDA may choose to close out the Warning Letter at that time. This typically follows multiple responses and a large amount of communication with the FDA.
Are Warning Letters Public?
Yes. Warning Letters are public and made available through the FDA website. They are not removed from the website unless the letter is amended or rescinded. Any confidential information is removed before the Warning Letter is posted, and replaced with the term (b)(4).
An individual or company can also request to have their response to the Warning Letter posted on the FDA website. The responses are included on the page along with the Warning Letter.
If you would like some examples of Warning Letters with commentary, you can check out our Warning Letter of the Week articles.
How serious is an FDA Warning Letter?
While a company should take a Warning Letter seriously, they are intended to allow a company to voluntarily comply with the law before the FDA initiates enforcement actions. A Warning Letter is a way for the FDA to say that there are activities that might warrant enforcement actions, but if the company can correct those activities the actions may not be enforced by the FDA.
There are also times when the violation is so severe, that the FDA gives a Warning Letter at the same time as they perform a seizure or other activity.
While a Warning Letter is typically a push for voluntary action, not performing corrective actions can lead to multiple different enforcement strategies. These include “recall, seizure, injunction, administrative detention, civil money penalties and/or prosecution to achieve correction” (FDA).
An FDA Warning Letter can also be administered as evidence in a lawsuit regarding the liability of a product.
Which industries receive Warning Letters?
Many industries that are regulated by the FDA can receive Warning Letters. These include:
- Pharmaceutical companies
- Food and beverage companies
- Veterinary food and medicine companies
- Medical device companies
- Medical device resellers
- Suppliers to these industries
Companies in various industries can also receive a Warning Letter if they advertise a product as a drug or medical device. This can commonly be seen in the supplement industry, where the FDA determines that the advertised material led a supplement to be classified as a pharmaceutical.
FDA Warning Letters for Medical Device Companies
FDA Warning Letters are commonly given to medical device companies if the FDA does not feel that the violations listed in a 483 were handled sufficiently. They require prompt actions and a well-running corrective action procedure.
The violations are most commonly found during FDA inspections, which are “required” every two years for Class II and III medical device companies. They are also found during inspections that stem from a complaint or trend in complaints. If a Warning Letter is in process, it can hold back a new device from getting premarket approval from the FDA.
Some examples of Warning Letters given to medical device companies are:
- An electric wheelchair importer and distributor failed to control documents and performed improper labeling and relabeling activities. One case of this was the company repackaging devices without providing a new UDI for the device.
- A company manufacturing endoscope accessories did not initiate a CAPA after over 150 complaints related to the same issue with the same product. They also set up their complaint handling procedure so that any issue which needed to be reported would not require the initiation of a CAPA.
A medical device company must have strong procedures and understand the risk of their devices if they are going to avoid getting a 483 notification or FDA Warning Letter.
What are the most common Warning Letters for Medical Device companies?
FDA Warning Letters are most commonly given to medical device companies for not establishing or following written procedures. While the FDA does not provide data on which procedures generate the most Warning Letters, this information is provided for 483 notifications.
While the procedure which generated a 483 notification is not necessarily the same one that received a Warning Letter, they are fairly similar. The areas which most commonly generate 483 notifications are:
- Corrective and Preventive Action procedures not properly established or followed
- Inadequate complaint handling procedures
- Processes not properly validated
- Lack of purchasing controls
- Nonconforming product procedures not properly established or followed
Wrapping Up
That was all you need to know about FDA Warning Letters. One of the best places to find out what types of issues warrant a Warning Letter and how they are addressed is our Warning Letter of the Week articles. You can also sign up for our email list below to stay up to date with different FDA Warning Letters and helpful information for medical device companies.