Aug 12, 2021 Kelly Stanton

How to Respond to FDA Warning Letters

What’s the fastest way to ruin a quality manager’s day?

Receiving a warning letter from the United States Food and Drug Administration (FDA).

Unfortunately, thousands of medical device and biopharmaceutical startups fall out of compliance with FDA regulations. These kinds of issues prevent even the most growth-oriented life sciences companies from achieving terminal velocity. 

And without an electronic quality management system (eQMS) by your side, mitigating quality and compliance issues is virtually impossible.

So, what’s the best way to respond to FDA warning letters?

Keep reading for a breakdown of the mission-critical steps your life sciences company needs to follow to adequately reply to an FDA warning letter. 

Use the expert insights found in this article to identify the corrective and preventive actions (CAPA) that your company needs to take to resolve quality issues quickly and efficiently — enabling you to bring products to market faster.

How to Respond to FDA Warning Letters: 3 Major Observations

Have you recently received an FDA warning letter? If so, don’t panic.

Start by taking a deep breath. Read the warning letter carefully. 

The FDA typically issues warning letters when manufacturers violate major rules and regulations. After receiving the warning letter, you must outline your response plan and provide a rough timeline for completed corrections. The FDA may then schedule an on-site inspection to ensure that all corrections are satisfactory.

If you’re unsure of how to respond to an FDA warning, we’ve outlined the three most common types of warning letters below with a quick response plan for each.

1. FDA 483 Observation Notice

FDA’s Office of Regulatory Affairs (ORA) may issue an FDA 483 observation notice after the organization identifies a compliance or quality violation during a routine facility inspection.

If you receive an FDA 483 observation notice, we recommend responding within 14 business days. Your written response should include the following elements: 

  • Acknowledgment of the 483 notice
  • Statement outlining your company’s commitment to resolving compliance issues
  • Confirmation of CAPA procedures
  • Timeline for the complete resolution of all citations
  • Documentation supporting all design control and quality assurance procedures

RELATED READING: Quality Assurance vs. Quality Control: What’s the Difference? 

2. General Warning Letter

The FDA issues a warning letter after witnessing compliance or quality violations during an audit or inspection. Unlike the FDA 483, a warning letter does not include the recommended actions that your startup or scale-up should take to resolve the violation.

In recent years, the FDA has issued an onslaught of warning letters related to quality procedures documented under 21 CFR Part 820. 

For this reason, more and more life science companies are relying on Qualio’s quality management system (QMS), a results-driven quality tool used to document quality procedures and design next-generation medical devices and biopharmaceutical products that align with new and evolving FDA regulations.

If you receive a general warning from the FDA, we recommend responding within 15 days of receipt. 

As a best practice, consider including a detailed description of your standard operating procedures (SOPs), as well as a brief overview of your CAPA response plan.

RELATED READING: The 8 Essential Functions of CAPA Management

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3. Close-Out Letter

An FDA close-out letter is only issued after corrections are deemed satisfactory.

According to the FDA, a close-out letter: 

will not be used based on representation that some action will or has been taken. The corrective actions must actually have been made and verified by the FDA. Usually, the standard for verifying that corrections have been implemented will be a follow-up inspection.

Great news! A close-out letter does not require a written response. 

However, future inspections will measure the long-term effectiveness of corrective actions.

RELATED READING: Identifying the 4 Most Common Problems With Your CAPA Process

Documenting Your CAPA Process with an eQMS

Designing a results-driven CAPA process is the only way to prevent compliance or quality issues from recurring. 

Following the aforementioned procedures and implementing permanent corrective actions will dramatically reduce your chances of receiving repeat FDA 483 observation notices or warning letters.

Avoiding these kinds of roadblocks is absolutely essential — especially if you’re preparing to introduce your medical device or biopharmaceutical product to market in the near future.


If you think your CAPA process might be lacking, we recommend taking our free self-assessment. The entire quiz only takes a few minutes of your time, and it’ll give you all the insights you need to level-up your quality and compliance programs. 

Once you’re done, you’ll even have an opportunity to connect with one of our quality professionals to discuss your results live!

Today, hundreds of quality professionals at some of the most impressive biotech, pharma, and life sciences companies in the world rely on our eQMS to power their quality programs. 

Which begs the question: Are you ready to use quality as a competitive advantage?

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Published by Kelly Stanton August 12, 2021