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Life After An FDA Form 483

April 7th, 2014 by

FDA Form 483 Warning LetterFDA inspections don’t always end smoothly. Field agents may decide that the deficiencies they observed were significant enough to issue letters detailing outstanding issues. For firms that want to bring their products to market quickly, receiving these FDA Form 483 letters could potentially represent major setbacks in the marketing process.

An organization should always opt for preparedness to reduce its risk of receiving of FDA Warning Letter, even if that means hiring experienced third-party consultants.  However, should you find your company on the receiving end of a 483, it is imperative to understand the proper way to respond to the FDA.

Understanding the Form 483

A Notice of Inspectional Observations often precedes an official FDA warning letter, meaning that the preliminary notice can serve as a good indicator of corrective actions your firm should make. Although these forms are generally issued and given to the organization during the close-out meeting at the end of an inspection, it’s possible to prepare for them by being proactive during the inspection itself.

Inspectors often make some verbal note of deficiencies before formally annotating them. While this isn’t necessarily guaranteed, training your employees to respond to such observations can help your firm prepare for any official notice letters. For instance, an employee who makes note of a procedural deficiency and compiles information showing that proper procedures were indeed performed may enable his or her firm to contest the observation later.

Under normal circumstances the inspector will usually leave the company’s premises around early evening on the days of inspection. This gives the employees of the firm enough time to prepare the necessary evidence in order to contest the observation starting the following morning. However, one must be aware that the evidence used to contest the observation should be prior to the inspection date and must comply with Good Documentation Practices.

Read this article to discover more about establishing FDA compliance.

Dealing With The Close-out Meeting

Say your firm does receive a Form 483 letter. There are numerous ways to address noted problems before they result in a Warning Letter, but it’s critical to choose an appropriate strategy.

Although it’s reasonable to point out potential errors and bring up corrections that have already been performed, you need to be careful about agreeing to make changes just to avoid further scrutiny. Your verbal statement of intent to take action may be recorded as an official commitment, and tying your hands without actually evaluating the scope of the problem will only make it harder to maintain compliance.

Also remember that arguing with the inspector might give the impression that your firm was unwilling to change or that you failed to understand the issue at hand. Some companies simply accept their Form 483 letters and assess them in private before deciding how to respond.

Improving Quality System Deficiencies

Following the receipt of an FDA Form 483, firms have 15 days to respond. While you are not compelled to respond to a 483, you would be well advised to provide the FDA with a written response, indicating the course of action you intend to take in order to mitigate the observation and ensure compliance in the area in which the 483 was issued. If you fail to resolve the deficiency, you may be subject to further reviews, so it’s important to craft a well-formulated response that actually addresses the problems at hand.

Your organization is responsible for demonstrating that you’ll implement changes or new corrective and preventative actions that not only correct the noted problems but also deal with other potentially related issues within the affected Quality Systems. You’ll also have to outline how you’ll complete your plan of correction action within a given time frame and delegate the work. Although it’s a job in and of itself, responding to FDA Form 483 letters in a prompt, thorough manner is essential to concluding your inspection and avoiding regulatory action.

GxP-CC is a leading team of compliance consultants who help life science firms through each phase of the compliance process. With experience with FDA, EU and other regulatory authorities, they can assist you with any of your compliance needs. Contact them today to speak with one of their expert consultants.

About this author:

Dr. Hussein has over 15 years of experience in the GMP industry as a successful advisor for top medical device and pharmaceutical companies. In 2008 Dr. Hussein was named as an assessor for project management in the “German Society for Project Management” (GPM). Dr. Hussein holds a Master’s in Physics and a Master’s in Biomedical Engineering from the University of Hannover in Germany. He also holds a PhD in Physics from the University of Luebeck in Germany.

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