FDA Warning Letters

One of the most effective tools




By a Former FDA Compliance Officer

One of the paramount objectives of a medical device or drug manufacturer is not to receive FDA Warning Letters. If there is a stronger word, I will use it. Do everything you can to avoid receiving a warning letter in the first place. Nothing is more expensive than fixing it after the fact. Therefore, avoid it at all costs. The primary reason for mock FDA inspections is one of the steps that will help. Don’t wait until you receive a notification of FDA inspection for a mock inspection. Again, we cannot emphasize enough the importance of complying with the FD&C Act. More importantly, you will need to hire a qualified auditor.

Please note that this article does not represent the FDA or its position. The FDA may updates its regulatory policies from time to time. Therefore, this article may not be accurate. Please check the FDA website for up-to-date policies and guidelines. In addition, this article is solely based on a limited experience working as a field and center Compliance Officer. As such, we do not claim that we can remedy your current conditions or situations with the FDA. We are not here to fix the problem, but to act as a consultancy and for advisement. Click here to read our disclaimers.

What are FDA Warning Letters?

The US FDA is a federal law enforcement agency. Therefore, if you are a medical device, drug, dietary supplement, food, or biologic company and violate FDA laws or regulations, the FDA may issue a warning letter. It’s a means to formally ask to fix violations you are committing, whether intentionally or unknowingly. However, it’s not the only tool the FDA has to enforce the FD&C Act, but it is one of the most effective tools it has.

The warning letter is an official public record. Anyone who has access to the internet can see FDA warning letters. Of course, any personal or other confidential information has been redacted (crossed out). They are public records, which means your competitors can use them against you. Also, news media, consumers, and even lawyers have access to warning letters. Get the idea? Therefore, don’t take the chance of bad publicity and put your company in jeopardy.

The Implications of FDA Warning Letters

If your company receives FDA Warning Letters, there are many consequences. Further, it may cause immediate complications for your company in conducting your business.

  • For an international company, FDA may put your company on its import detention list. This is to prevent your “violated” products from being distributed in the United States.
  • For a domestic company, you may not be able to sell your products to federally funded businesses, including hospitals. Sometimes, it can cause you to shut down your manufacturing operations until violations are resolved.

When does the FDA Issue a Warning Letter?

The federal agency issues FDA warning letters to the violators of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or United States Code, Title 21. It’s a form of formal warning that you are in violation of a specific law. The letter could be triggered by poor manufacturing practices, unsubstantiated claims for a product’s intended benefit, improper directions for its use, or other adulteration or misbranding conditions. For example, if the manufacturer or distributor of dietary supplements claims that their product prevents or cures a certain condition. Another example is a poor manufacturing practice, such as not validating a sterilization process.

The FDA Warning Letters clarify that you must correct the violations, including details of how and when you must do so. Therefore, you must present a plan including corrective actions that you will take by writing a response letter or meeting with the assigned Compliance Officer. However, a meeting with a compliance officer is not necessarily better than writing a response letter. In fact, one session or one response letter may not be sufficient and may be subject to subsequent interaction.

You can receive FDA Warning Letters without advance notice.

There is no specific timeframe or guideline for when the FDA will issue its warning letter. It can come a few months after the close of an FDA inspection. Or it may appear out of the blue without an onsite inspection. Because the FDA did not inspect you or you did not receive Form-483, Inspectional Observations, does not mean you are exempt from receiving a warning letter.

Warning Letter Close-Out Letter

If you received a warning letter from the FDA on or after September 1, 2009, FDA might issue a close-out letter if your response to the warning letter is satisfactory. It includes your actions to correct violations listed on the FDA warning letters. Of course, the assigned compliance officer must verify and accept all corrective actions. This is the reason you should seek a professional to write the response to the warning letter. The FDA may not issue the close-out letter until they conduct another onsite inspection to verify you corrected the violation according to the regulations. However, the agency may employ stronger enforcement action without further notice if your corrective actions are inadequate during a subsequent inspection.

How to Avoid FDA Warning Letters

If any consultant promises that they can completely protect you from receiving a warning letter from the FDA, they are not telling you the truth. No one can make such an egregious claim. However, you can minimize the chance or the significance. How? Educate, train, practice, and practice again with your staff. This is where we come in. One of the tools we use is the mock FDA inspection.

However, if it’s too late for a mock inspection and you receive a warning letter, AP Consulting can help you.

Our consultant was a former FDA field investigator and compliance officer. Therefore, we can help you to understand the seriousness of the violations and how to correct them as best you can. Also, we may even have to involve other specialists and experts during the process. It may not be a one-person task. But we can help you because we know where to start. Please note that resolving FDA warning letters can take months or even years. Therefore, you must not spare anything to prevent it from being issued in the first place. Remember, the warning letter is serious, but worse yet there may not be a second warning letter.

This analogy is not the best approach, but it may help you understand the seriousness of a warning letter. Imagine, for example, that you are a renowned oncologist. A recently diagnosed cancer patient comes to you for treatment. Suppose the patient asks you if you can cure their cancer. Your answer most likely will depend on the seriousness of cancer. If the cancer is “fixable” and in the early stage, you may tell the patient that you can’t promise, but you can try. Of course, it may take a few months or even years. Then, you will inform the patient that cancers may recur even when they appear to be fully “fixed” with chemotherapies and drugs and are in remission. Now, that’s the patient with curable cancer…

Do you still think a mock FDA inspection is too expensive or redundant?