The FDA is required to inspect Class II and III medical device companies every two years. What happens if the FDA observes something that violates good manufacturing practices during the inspection? This is where an FDA Form 483 comes in. An FDA Form 483 is a documented notice of regulatory violations observed during an FDA Inspection.
An FDA 483 observation can be a breaking point for a medical device company, and lead to a significant investment down the line if not properly addressed.
To make matters worse, a 483 observation is not a rare occurrence, as there were 538 FDA Form 483s generated for medical device companies from Oct 2021 – Sept 2022. And this is during a time when FDA inspections are still at a low after the Covid-19 pandemic (for reference, medical device companies received 822 Form 483s in 2019).
Let’s explore more about FDA Form 483s, and how they could impact your company.
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What actions lead to an FDA Form 483?
An FDA 483 observation is given to a company at the conclusion of an FDA inspection if the FDA inspector has documented any situations which may violate the Food and Drug Act. For a medical device company, these usually include instances where there are no written procedures in place or the procedures were not properly followed.
Based on data provided by the FDA, we can look at the top five areas which resulted in FDA Form 483s for medical device companies:
- Corrective and Preventive Action procedures not adequately established or followed
- Inadequate complaint handling procedures
- Processes not properly validated
- Lack of purchasing controls
- Nonconforming product procedures not properly established or followed
While these are the most common areas for generating 483 observations, any process which is mandated by FDA regulations can be subject to an FDA finding.
If you are used to the terminology of ISO 13485, a 483 is the equivalent of an audit finding (a major finding, of course, who do you think you’re dealing with?). There are, of course, much more serious consequences for a 483 observation. Down the line, the observation could escalate to a Warning Letter, fines, or the company being shut down.
Responding to an FDA Form 483
When you receive a 483, you should respond to the FDA in a similar way you would respond to a major audit finding. Using your CAPA procedure to document actions, you will have to send in your written response in the time frame provided by the FDA.
The response should list the steps you have taken to address the issues identified during the FDA inspection. It should be very easy to understand, have all items stated clearly, and use as much data as possible to back up any claims.
If there are any observations that will take longer than 15 days to correct, you will want to provide the FDA with the detailed steps in which you will complete the actions, as well as a specified timeline for when the actions will be complete.
This is not the time to mess around, plan corrections to be completed way down the road, or extend deadlines to implement corrective actions. No matter what your internal procedure says, you do not have the leeway to address the concerns at a snail’s pace. Your actions should be swift, decisive, and inclusive of the entire procedure or area which generated the FDA finding.
Closing out an FDA Form 483
If your initial response to the FDA included the completion of all necessary corrective actions, the FDA may accept your response at that time. More likely, you will need to send consistent updates to the FDA about your progress in completing all necessary actions.
The FDA may send back responses or questions to any or all of your updates. Once all of your actions are complete, inform the FDA that you feel your actions are adequate. At this time, the FDA may accept your response, and will likely follow up with a re-inspection to confirm all items have been successfully addressed.
Are 483 observations public?
Kind of. A 483 can be requested by any organization or individual through the Freedom of Information Act Office. However, the request will not be answered immediately, and you will actually need to pay for the time spent accessing the information.
This is different from FDA Warning Letters which are directly posted to the FDA’s website for public access. While a medical device company certainly does not want a 483, it will not be posted for the world to see in a similar manner as a Warning Letter.
What is an FDA Warning Letter?
A Warning Letter is issued by the FDA if they have found significant violations of applicable regulations. In the case of a medical device company inspection, an FDA Warning Letter is typically considered an escalation of a 483 observation and is issued if the items in the 483 observation are not addressed.
A Warning Letter may also be issued if the findings are of such severity that the FDA needs to immediately escalate the finding (there are several other types of Warning Letters related to product claims in marketing material or an inaccurate IFU). Additionally, an FDA Warning Letter can be issued in tandem with an FDA Form 483, if there are multiple findings with different severities.
An FDA Warning Letter has more severe consequences than a 483 and is posted to the FDA website, which can be a massive risk to the company. Learn more about Warning Letters in FDA Warning Letters: Everything you need to know.
Wrapping Up
That is everything you need to know about FDA Form 483 for medical devices. If you would like to help your company avoid any 483 observations, be sure to check out our FDA and ISO 13485 sections and sign up for our newsletter below. They have lots of articles to help you make great procedures and avoid any findings.
Also, if you are interested in learning more about Warning Letters and getting some real-life examples of what the FDA cites as significant issues, check out our Warning Letter of the Week articles.
If you have any questions or ideas, feel free to leave them in the comments below.