In previous entries on the Pearl Pathways blog, I have discussed what to do when you are asked questions by regulators, when FDA inspectors show up at your facility, and when you receive an FDA Form 483. This time, I will address what to do when you get a Warning Letter from the FDA.
I like to equate an FDA Warning Letter to a round that the Coast Guard fires across the bow of a ship. Their goal is not to hit the ship, but to gain the attention of the ship’s crew in a big way; they want the ship to immediately stop and begin cooperating.
What is a Warning Letter?
A Warning Letter is typically the result of an inspection by FDA that has revealed serious shortcomings in the way that drugs or devices are manufactured and released. The letter will generally say something like, “The inadequacy of your quality system renders your products adulterated.” This is a legal term and refers to the Food, Drug, and Cosmetic Act. What it means is that FDA is legally allowed to seize your products and stop you from selling them until the quality issues are resolved.
This should get your attention in a big way. The rest of the letter will spell out the specific issues that you have to address, backed up by the findings of that recent inspection. None of this should come as a surprise: during the inspection, at the end of each day, the inspectors would have identified areas of non-compliance they observed that day. And at the end of the inspection, there would have been a closeout meeting in which key issues were presented to you in the FDA form 483.
How to react to an FDA Warning Letter
So, what do you do? If the FDA seizes your products and will not permit you to sell them, this would result in serious financial difficulties for your firm. You must take action. Here are the key steps:
- Get senior management aligned on the seriousness of the situation and committed to do what is necessary to resolve it.
- Identify the personnel who will take the lead in addressing each of the FDA findings.
- Make sure that these personnel have resources they need to do so.
- Develop a timeline for bringing your firm into compliance.
- Communicate all of this to FDA.
This is not a simple process. Even if you follow the five steps above, there will be a significant credibility issue to address. You were handed the Warning Letter because your quality system was recognized by inspectors as seriously deficient. Why should FDA believe that you are able, or even willing, to fix it yourself?
How can you get past this credibility problem? The best solution is to partner with a firm with extensive experience in FDA’s Good Manufacturing Practices (GMPs). In effect, you can leverage their credibility. So, if you say to FDA, here is what we are going to do to fix the problems, they are likely to respond, why should we believe you? On the other hand, if you state that you have hired a firm with many years of experience in GMPs, such as Pearl Pathways, then you are able to utilize your partner’s credibility as you work to remediate the identified gaps and rebuild credibility with the agency.
If FDA has issued your firm a Warning Letter, Pearl Pathways can help. Our Quality and Regulatory team has over a century of experience in GMPs. We can help you navigate this difficult process through a number of measures; we can:
- Audit your facility before the FDA shows up, identifying problems so that they can be fixed before the inspectors arrive.
- Assist you during an FDA inspection, working with your staff to ensure the best outcome.
- Help you respond to an FDA 483, creating a plan to address the inspection findings that you can share with FDA.
- And, if you get that Warning Letter, we can partner with you to resolve the issues identified by regulators and get you back on the right track.
Read the other blogs in this series: