How to Properly Decipher an FDA Form 483

In your role, you’re likely responsible for vetting potential supplier partners on behalf of your hospital or GPO. You’ve been given the task to request each Form 483 and decipher all the complex jargon of the FDA. While this may seem like rocket science to others, it’s your responsibility to know how to simplify the complexities of FDA Form 483.

The FDA confirms that the issuance of Form 483 is one of the tools in their enforcement bag. The main goal is to attempt to extract a voluntary correction of objectionable conditions by the agency. While issuing a 483 is not the final regulatory action from the agency, it sends a message like being late for your job without notice and you get a firm lecture. You are not fired, but your boss is not happy either.

Now, if an organization is a Form 483 recipient, it doesn’t necessary mean they’ll get a warning letter during the close of an inspection. The FDA investigator is responsible for writing the Establishment Inspection Report (EIR) at the end of an inspection. From that point, the completed EIR is up for review at the local district office. The reviewer can determine the deficiencies in an establishment’s quality by looking at the content and evidence depicted in the EIR points. Like your job if you keep being late, the FDA will take the next steps and give a warning letter.

Since April 2009, the agency has created a policy of automatically issuing warning letters to establishments failing to respond to a Form 483 within the 15-day time period.

Here are some things to review on the form:

1.) Context

Having general understanding of the context can make it easier to find out the true nature of the letter. It’s this foundation of being aware of 483 that doesn’t necessarily inform you of the true nature of the problem. As an example, you get a review at your job that explains all the areas you need to improve. It doesn’t point out one example or occasion. With the content in a 483, it does help you see the following

2.) Severity of the Problem

The scale of the problem is mentioned in this form. The FDA observes the type of impact that’s presented due to an unforeseen issue. The severity is presented, but not the main cause of it. It’s the organization’s job to investigate and rectify the root problem. Like an employee, it is their job to implement change and improvement after a company review. An organization should look at the 483 as a need for change and implementing those processes, so there aren’t issues in the future.

The key reason for this is due to how the letters are distributed. The department uses a process that screens a suitable category of problems, after which the rest of the letter follows. This can overcomplicate things due to the nature of the problems. It’s essential to review the content from the drop-down menu in the section that starts with “specifically”. There you can find the true nature of the comments about the facility being reviewed.

3.) Issue of Extensive Examples

Another issue (besides the vagueness of the warning letters) is the extensive examples. The FDA provides a list of different examples of potential issues that could have triggered the warning letter. However, this is time-consuming, because the organization must determine the true issue from several possibilities that could be non-applicable to the situation.

4.) Length

The length of the 483s can be good determinant of the true nature of the problem in the facility. Shorter ones could indicate a trivial issue; longer ones could be more serious. It varies in severity from a single serious issue to several problems being concurrent. Each investigator will have their method of the review, and one should always ask questions if there is any confusion.

5.) Data Integrity Issues

The integrity of the data could be particularly problematic. There could be several underlying issues that potentially affects all systems within an organization.

6.) Mention of Repeat Observations

Another issue is that of repeat observations in a 483. If several observations are repeated as a potential issue, it holds more weight than a single instance of an observation, which may likely result in a warning letter.

7.) The Nature of Enforcement

The US FDA enforces these policies in a more progressive approach. They don’t enforce it forcibly on the organization. Instead of penalizing facilities right away after seeing a potential issue, they want to ensure that any necessary changes are carried out voluntary.

If the violation is repeated and there’s no sign of complying with the request, then the FDA becomes strict in their nature. For the most part, when the FDA issues a 483, it doesn’t necessarily mean that something is wrong. In fact, almost all 503B organizations have been issued one, and the ones that haven’t may not have been inspected yet.

In evaluating different facilities, take all 483s seriously. Organizations need to be more open-minded and transparent and provide you with a copy of the letters they receive. Additionally, they need to give a detailed plan of their current process of resolving any outstanding issues, and how they’ve showed that information to the FDA.