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Dealing with FDA Warning Letters Before They Become a Problem

June 23rd, 2014 by

FDA Warning LettersMost life-sciences firms would agree that the best way to prepare for FDA Warning Letters is to take measures that prevent them from ever coming. Unfortunately, regulatory compliance is a complex beast, and it’s rarely possible to do everything perfectly.

Comprehensive compliance and quality management implementations may, however, make it much easier to respond to FDA Warning Letters and minimize their negative impacts.

Why Do Firms Receive Warning Letters?

Contrary to what some believe, the FDA doesn’t simply send out warning notices without provocation. In most cases, the agency is motivated to do so in response to issues discovered during previous inspections of production facilities. Firms may even get advanced warning in the form of a 483.

Regardless what prompts a Warning Letter, it has the potential to seriously hinder a firm’s forward progress. Because it is an official acknowledgement of the fact that a firm’s actions violate some part of the Federal Food, Drug and Cosmetic Act, it could be followed by enforcement actions that prohibit the said company from doing business.

Choosing the Way You Respond

The FDA expects that your firm will take action to change the way it operates after you receive a Warning Letter. While such actions usually come in the form of a corrective and preventative actions (CAPA) submission, they don’t necessarily have to represent major upheavals in the way your company operates. Your company must however ensure that suitable mitigating actions are introduced via your CAPA system.

For instance, firms that already maintain effective deviation management and CAPA systems may not have to work as hard to submit an acceptable plan. Because these companies are already familiar with the steps they typically need to take to implement effective changes in their manufacturing and supply chains, they can adapt previous solutions to the current situation.

Having an existing CAPA system may also make it easier to verify the efficacy of plan submissions so that they stand up to agency scrutiny. Past CAPA data can be provided upon request to demonstrate that new proposals are not entirely without precedent, and this may induce the FDA to grant its approval for the remediation plan.

The Importance of Strategy

Firms that don’t take the possibility of Warning Letters into account may find it extremely difficult to deal with them without major issues. Warning Letter responses typically have 15-business-day deadlines, meaning firms won’t necessarily have time to come up with comprehensive remediation plans if they’re caught off guard. Such companies are more likely to have to submit to enforcement as a result of their unpreparedness.

There are many ways to incorporate Warning Letter response strategies into one’s standard operating procedures, but not all methods bear the same efficacy. GxP-CC consultants have years of real-world experience helping medical device and pharmaceutical firms create and implement effective compliance and corrective action systems that permit them to deal with regulatory communication efficiently. Learn more about how they can help you handle a recent Warning Letter or prepare for the possibility of one by contacting GxP-CC today.

About this author:

Dr. Macartney began his career within the medical device and pharmaceutical fields where he was involved in research and development before moving to the central computer division of the company’s research division located in Upper Bavaria, Germany. In 1996 he started his career in the consulting industry. An industry-wide recognized expert who has issued various publications supporting industry standards, Dr. Macartney is also referenced by the National Academy of Sciences.

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