Best Practices for Responding to an FDA Form 483

The U.S. Food and Drug Administration (FDA) uses Form 483 to notify companies of issues identified during inspections. As the FDA explains, “an FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts. . . . Observations are made when, in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.”

Companies that receive Form 483 following an inspection need to respond appropriately. As the FDA explains, while Form 483 “does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act,” the FDA considers inspectors’ observations along with other evidence when determining whether enforcement action is warranted. By providing a complete and timely response, a company can reduce the chance of enforcement, mitigate risk in their operations, and set the stage for a good working relationship with the FDA.

FDA Guidance on Responding to Form 483

In June 2024, the FDA issued draft guidance for companies facing inspections—including guidance for responding to Form 483. While the draft guidance focuses on the bioresearch monitoring industry specifically, the FDA recommendations regarding Form 483 apply to other industries.

"A well-crafted and timely response to an FDA Form 483 is crucial for demonstrating a company's commitment to compliance and quality. By addressing each observation thoroughly and providing clear corrective action plans, companies can mitigate risk and maintain a positive relationship with the FDA." 

- Tim Philips, Specialist, Gardner Law, Consultant, Gardner Law, Biomedical Engineer, and Former FDA Compliance Officer and Investigator

• Per the draft guidance, a company’s response to Form 483, “should demonstrate . . . acknowledgement and understanding of FDA’s observations. . . [as well as a] commitment to address the observations, including a commitment from senior leadership.” The draft guidance calls for well-organized responses. 
• Address each observation discussed in Form 483 separately
• State whether the company agrees with each observation (and why or why not)
• Discuss corrective and preventive actions (including timelines for completion)
• Provide a method of verifying or monitoring effectiveness, and include relevant documentation such as training records, Standard Operating Procedures (SOPs), corrective action plans, etc.

In their Compliance Program Guidance Manual (CPGM 7382.845) for Inspection of Medical Device Manufacturers, FDA provides insight into their review of 483 responses. FDA states:

“All reasonable efforts to achieve voluntary compliance will be considered before initiating regulatory action, if received in a timely manner after an inspection closes. Corrections and corrective action proposals and plans, including evidence of corrections implemented, should be submitted by the firm in writing within 15 business days of the inspection close...” - thus emphasizing the importance of being timely in a response to a Form 483.

Before crafting and submitting a 483 response, companies must first address the substance of the investigator’s observations. Are the observations accurate? If so, what remedial measures are necessary? If any of the observations are inaccurate, is documentation available to prove it? Will a nuanced discussion with FDA be helpful? These are just a few considerations that go into protecting a company’s interests following the issuance of Form 483.

Need Help Responding to an FDA Form 483?

If your company has received Form 483 following an FDA inspection, our team can assist with formulating and submitting an appropriate response. Contact us to schedule an initial consultation with Gardner Law.