483 vs Warning Letter: What’s The Difference?

by | Oct 14, 2019 | Enforcement Actions, FDA, Medical Devices, Quality Systems, Warning Letter

The terms “Form 483” and “warning letter” can incite dread for those that market their medical device in the US, but what exactly are they and how do you deal with them? To begin it’s important to note that an “FDA Form 483” and a “warning letter” are a part of the same process but are two different things.

A 483 is issued to a company at the end of an FDA inspection, it documents any conditions that the inspector believes may violate FDA regulation. Its purpose is to notify the company’s management of any conditions observed and allow them to discuss and respond. Once you have received the 483 you only have 15 days to respond thoroughly. A response to a 483 should address each item and provide a timeline for corrective action.1

A 483 is not considered a final agency determination, so it is only a piece of what the agency looks at when determining a company’s compliance. A separate inspection report (the Establishment Inspection Report, completed by the inspector) and your response (which is why it’s important to provide a thorough and timely one) are also evaluated to determine a final judgment. If the agency determines that a serious violation may exist, you will receive an FDA Warning Letter. When you receive a warning letter it is imperative that you create and implement corrective actions and have a detailed plan laid out for every finding. If you responded to the 483 and still receive a warning letter, simply resubmitting your response will not suffice. A warning letter is a serious escalation of any observations during your inspection; they have mandatory requirements and are made public so anyone can search for them online.2

The escalation from a form 483 to a warning letter is something every medical device company wants to avoid, which is why it’s critical to respond to any 483 observations as seriously as if they were enforcement actions. This is the time for the upper management team to analyze their quality system and any processes with nonconformances. While the whole process may feel intimidating, ultimately, it’s the goal that the company will come out on the other side with an improved quality system.

With all the work that needs to go into 483’s and/or warning letters, it is beneficial to consider obtaining some outside experts to help your team through the process. EMMA International has the regulatory expertise to help your team analyze any 483 and/or warning letter findings and respond to the agency effectively – give us a call at 248-987-4497 or email info@emmainternational.com for more information!


1FDA (July 2019) FDA Form 483 Frequently Asked Questions retrieved on 10/08/2019 from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions

2FDA (September 2018) Letters To Industry retrieved on 10/09/2019 from https://www.fda.gov/medical-devices/industry-medical-devices/letters-industry

Emma International

Emma International

More Resources

FDA’s Refusal to Accept Process

FDA’s Refusal to Accept Process

Before the submission of a 510(k) premarket notification, the purpose of which is to notify the FDA of the manufacturer’s intent to market a medical device,[i] there is a provision for acceptance review. This review serves as a method to assess whether a submission is administratively complete and includes all necessary information for FDA to determine substantial equivalence under section 513(i) of the Federal Food, Drug, and Cosmetic (FD&C) Act (21 United States Code (U.S.C.) § 360c(i)). To establish substantial equivalence under this provision, FDA must find the same intended use as the predicate device and either have the same technological characteristics as the predicate device or appropriate clinical and scientific data necessary to establish that the device is safe and effective as the predicate device. If the Authority is unable to determine substantial equivalence due to insufficient information, it may request for additional information to make that determination. Therefore, as a part of the acceptance review, the FDA staff follows the acceptance checklist[ii] to ensure that the application is administratively complete. These administrative elements are identified as RTA items and are required to be presented. The purpose of conducting the acceptance review is for the Lead Reviewer to determine whether the 510(k) submission meets the minimum threshold of acceptability and should be accepted for substantive review.[iii]
Empowering Your Workforce through Kaizen

Empowering Your Workforce through Kaizen

Last week, I touched on the idea of involving and empowering all employees in the workplace through the corrective and preventive actions process by fostering taking initiative and a problem-solving (refer to blogpost ‘The Art of Addressing Non-Conformances in Operations’). To expand on this concept a bit further, we’re going to be looking at Kaizen–a continuous improvement strategy in which employees at all levels are also empowered to solve problems towards big gains.
FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

FDA’s draft guidelines on Remote Regulatory Assessments (RRAs)

The pandemic has been a challenging time for all industries including the Food and Drug Administration (FDA). The FDA had to alter the manner in which it conducted its operations. One set of tools adopted by the FDA in response to COVID-19 was the remote regulatory assessment (RRAs).

Ready to learn more about working with us?

Pin It on Pinterest

Share This