FDA 483 Response: Four Tips to Avoid a Warning Letter

August 25, 2016 Victor Chance and Judith Meritz



The receipt of a 483 at the conclusion of a facility inspection notifies a company of conditions the FDA believes are in violation of the Food, Drug & Cosmetic Act. If 483s are not properly addressed, the FDA can take further enforcement action to protect the public health – including issuing Warning Letters. Warning Letters not only indicate potential risks to patients, but also bring unwanted publicity, erode patient trust, and potentially restrict the approval of future products significantly impacting revenue. Therefore, companies must know how to mount a competent response.

In a recent webinar hosted by YourEncore, we outlined four steps medical devices companies can take after receiving a 483 to successfully allay FDA concerns and prevent further enforcement actions.

  1. Understand the process. Once an inspection takes place and deficiencies are found by the FDA, a Form 483 is issued. It is important to respond to the FDA within 15 days to ensure that the FDA considers your response before taking further enforcement action. The response should detail how the company is addressing the FDA concerns and specifically how these problems will be avoided in the future.  How these issues are addressed will determine whether or not the FDA will take additional action.
  2. Address and avoid common problems. Deficiencies tend to fall into three main areas: insufficient complaint handling, poor Corrective and Preventative Action (CAPA) procedures, and deficient Critical to Quality (CTQ) control in the supply chain. In a follow-up inspection, the FDA will look for data to prove that the company has found and fixed deficiencies, so they won’t happen again.
  3. Provide competent responses. A good response must convey a sense of urgency to address the problem. Lay out a specific plan with action items, dates and commitments. The timetable should provide scientific justifications. The plan also should include a commitment to allocate the necessary resources to make the needed corrections. This includes not just addressing the individual item listed by FDA, but also larger systemic issues. Outline a commitment to long-term quality and speak about changes as enhancements to existing policies and procedures.
  4. Speak to issues. The most important thing in communicating with FDA is to show why the problem won’t reoccur, so document the root cause and corrective action. Speak to the specific concerns of FDA. FDA wants to know exactly what’s being done and who is doing it. Clearly document the situation, include specifics, and explain how the corrective action will address the problem. 

Regulatory inspections are required as part of FDA oversight of medical device companies. Knowing how to handle 483s quickly and thoroughly can have a major impact on the success of your company.

To listen to the FDA 483 Response Best Practices webinar, click here. To talk with a YourEncore expert who can guide you through the FDA process, contact Mary Ellen Schipp (Maryellen.Schipp@yourencore.com).

About Victor Chance: Mr. Chance is a Strategic Advisor and member of YourEncore’s Medical Devices Practice. Previously, he was the Vice President of External Operations and Chief Supply Chain Chief Procurement Officer for J&J Medical Devices and Diagnostics, and he also served as Worldwide Vice President of Operations for J&J’s Cordis franchise.

About Judith Meritz, J.D.: Ms. Meritz is a Strategic Advisor and member of YourEncore’s Medical Devices Practice. Previously, she was the Associate General Counsel at Covidien/Medtronic and specializes in compliance counseling concerning FDA and other international regulatory authority matters including inspections, enforcement actions, product approval strategies, marketing and advertising programs, and complaint handling.

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