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FDA Form 483 or Warning Letter Response

Understand Acceptable Versus Unacceptable with the FDA

Complying with the FDA and its countless regulations is complicated. That leaves many medical device companies at their wits’ end trying to figure out what they did wrong. Medical Engineering Consultants understands FDA regulations and compliance demands. Therefore, why waste time and money spinning your wheels with confusing — and often unspecific — Form 483 or Warning Letter language, when MEC speaks that language and can translate it for you?

If You Receive a Feared FDA Form 483, Know How to Respond

Some warnings are good because they give you time to take corrective action and make things right before they go too far wrong. However, a Warning Letter from the FDA means that you didn’t have the proper preventative actions in place and something has gone wrong that needs to be made right ... and fast. MEC has the FDA Form 483 knowledge to help you reply effectively. Here’s what else MEC medical device consultants can help you achieve:

  • Comply with FDA Requirements by making sure your GMP quality system is — and stays — completely compliant. 

  • Follow FDA Rules to the Letter by assessing, analyzing and determining the right time frame to respond to FDA 483 Forms, Warning Letters and Queries.

  • Implement Corrective Measures by strategizing the best course of action and incorporating it into your GMP quality system.

Whether you have received an FDA warning letter — or want to greatly reduce your risk of getting one — contact Medical Engineering Consultants.

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