Form 483s and warning letters from the U.S. Food and Drug Administration (FDA) require timely, well-thought-out responses.
What is an FDA 483?
The official name of the FDA Form 483 is “Notice of Inspectional Observations.” At the conclusion of an FDA inspection, the field inspector may issue what is referred to as a 483. The 483 form lists all of the observations noted by the Inspector during the inspection. The 483 is based on the field inspector’s evaluation of your operations, interpretation of the FDA regulations, and how this interpretation relates to your good manufacturing practice (GMP) quality system.
The field inspector submits the finalized Form 483 at the FDA. The 483 is publicly available through the Freedom of Information Act, and the FDA will eventually post it on the FDA Enforcement page. The company is required to submit a formal response and action plan to the FDA to address the 483 observations within 15 days of receipt.
The formal response to the 483 must include:
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Management commitment to address the deficiencies in a timely fashion
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Specific details about each deficiency and how the company plans on addressing the issue including the underlying root cause
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Systemic issues
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Timeframe for completion
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Objective evidence to support the corrections
The FDA can decide to escalate its action and issue a warning letter. A warning letter is more serious than the 483, although both are notices of violations. The FDA may issue a warning letter if the company:
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Fails to formally respond to the 483.
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Responds, but does not act to mitigate the issues.
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Receives recidivist findings during another audit at the same or a different company facility.
What is an FDA warning letter?
The FDA issues a warning letter when it believes a company has significantly violated FDA regulations. The warning letter describes the violation, issues a demand for corrective action, and includes a deadline for responding with a corrective action plan.
The company must formally acknowledge receipt of the warning letter and has 15 days to respond to the FDA. Typically, along with the formal response, the company includes a Quality Improvement Plan describing the specific actions to be taken and milestones for completion.
What should my company do if it receives Form 483 or warning letter?
You must respond in a timely manner and describe a corrective action plan to remedy the findings. You are expected to provide a detailed response for each finding. The quality and promptness of your response to the warning letter is important. The FDA may require a company that receives an FDA Form 483 or warning letter to hire a consultant to help address the findings.
Your company can access expert response help at Oriel STAT A MARIX. Our medical device consultants have extensive real-world experience responding to FDA 483s and warning letters. Additionally, we have assisted scores of organizations in implementing sustainable corrective action that meets the needs of the FDA and also improves the management system and operating performance of the company.
If you have received an FDA Form 483, a warning letter, or need immediate help during an FDA inspection, Oriel STAT A MATRIX can help.