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 …

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