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FDA Form 483 and Warning Letters: What's the difference?

By Stephen Fochios
May 17, 2016 10:30:00 AM


When the FDA comes in to inspect a pharmaceutical or biotechnology company’s manufacturing facilities they can either alert the company ahead of time or show up unannounced. After the inspection is over the FDA can send what is called an FDA form 483 or a warning letter. There are differences and various consequences depending on how these are both handled.

What is an FDA Form 483?

A form 483 is a list of deficiencies that that the FDA sends to a company post-inspection outlining what they think needs to be remediated.  It is strongly suggested that a company responds to these forms thoughtfully and aggressively with corrective actions. The FDA wants to make sure that you have significant control of your compliance program when involved in the manufacturing of drugs. Responding to these forms is usually a collective effort by many different teams in an organization.

It’s important to respond to the FDA Form 483 within 15 days as early response is necessary in order to avoid a warning letter.

What is an FDA Warning Letter?

When the FDA issues a warning letter, on the other hand, this becomes a more serious situation. A warning letter is usually issued for major compliance deficiencies that have been noted during previous inspections and previous 483s that have not been properly remediated. These letters should be taken very seriously and answered within the required timeframe. A well thought out plan needs to be implemented and adhered to and consistent communication with the agency is essential.  If the FDA feels the responses are unsatisfactory, they may take further actions to ensure compliance.

The key to successfully dealing with these types of findings by the FDA is to always remain in a state of inspection readiness.  Far too often companies become complacent and fall back into bad habits. It is very important that an organization has an inspection readiness team available at all times.  This will allow them to waste no time in collecting data and develop thoughtful and meaningful responses to the FDA.  I have seen companies blindsided by FDA inspections and scramble to reply in a timely fashion.  Every day should be treated as if the FDA will show up unannounced and ask to see how the company is remaining in compliance with the applicable regulations.

Learn more about how your organization can take the appropriate actions to ensure compliance: Take the Risks Out of Responding to FDA Observations. Do you have specific questions about FDA inspections and/or responding to notifications such as an FDA Form 483 or a Warning Letter? We would be happy to provide assistance – reach out to us at: [email protected].


Stephen Fochios

Written by Stephen Fochios LinkedIn

Stephen Fochios serves as a Principal Consultant for EG Life Sciences. He received his Bachelor’s degree in Biology from the University of Massachusetts at Amherst and has a Master’s degree in Medical Sciences and an MBA in Health Sector management and Finance from Boston University.

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