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FDA Form 483 vs. Warning Letters: What's the Difference?


When the FDA inspects 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 might send what is called an FDA Form 483 or a warning letter. There are differences between each and varying consequences depending on how each of these is handled.

What is an FDA Form 483?

An FDA Form 483 is a list of deficiencies 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 all pharmaceutical and biotechnology companies have significant control of their compliance programs, particularly when they are 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 an early response is necessary in order to avoid a warning letter.

What is an FDA Warning Letter?

An FDA warning letter, on the other hand, is a more serious situation. A warning letter is usually issued for major compliance deficiencies that have been noted during previous inspections and previous FDA Form 483s that have not been properly remediated. These letters should be taken very seriously and answered within the required time frame. A well-thought-out remediation plan needs to be implemented and adhered to, and consistent communication with the FDA is essential. If the FDA feels the responses are unsatisfactory, they may take further action 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 a Site Inspection Readiness team available at all times. This will allow them to efficiently collect data and develop thoughtful and meaningful responses to the FDA. Companies can be blindsided by FDA inspections, and they are then forced to 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 all applicable regulations.

Do you have 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: info@eglifesciences.com.

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