FDA Form 483

Home > FDA Form 483

As a medical device manufacturer, you are likely all too aware of the looming threat of that dreaded FDA Form 483. This letter indicates that an the investigator(s) has observed conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts or objectionable conditions found during inspection.

In a highly regulated industry, managing the everyday manufacturing process can be challenging enough. Tack on the added burden of this quality management nonconformity, and you’ve got a constellation of headaches and complexities that may prove too much for your in-house resources to handle. At the same time, the cost of nonconformance is too high to ignore.

How you respond can make or break the integrity of your company. We’ve got your back! We’ll help you quickly respond to the notice and address the violations in question.

Contact Us

FDA Form 483 Support:

We will assist you through your nonconformance complexities, ensuring you act quickly and proactively to resolve the issues in question.

With our QMS Compliance and Remediation Services, we’ll partner with you to:

Analyze the findings of the FDA Form 483
Develop a nonconformance management procedure to address the deficiencies
Create a timeline for implementation
Lead or assist in the implementation of the plan to address the deficiencies
Act as an interim management representative
Field questions from you or the FDA during corrective action activities
Develop a nonconformance standard operating procedure to ensure ongoing QMS compliance

Turn it over to Sterling

With our QMS Compliance and Remediation Services, you get a partner with decades of experience helping clients achieve and maintain regulatory compliance. Let us take on the burden of dealing with those dreaded “for-cause” inspections and nonconformance findings, and rest easy knowing you’re in capable and experienced hands.

To learn more about how Sterling can help you address the FDA Form 483, fill out the form.

Share this!

Resources

July 7, 2015

Should the FDA’s Regulatory Oversight of Medical Device Apps be Limited Any Further?

The medical technology (medtech) sector is ablaze with change as a result of the increased usage of mobile apps. Today, legislators, media outlets, and decision-makers in industry are increasingly...

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.

Sterling Medical Devices Creates Controller to Groundbreaking New Multi-Pump Mechanical Circulatory Support Device

Controller to Power Groundbreaking New Multi-Pump Mechanical Circulatory Support Device Medical Device Need A controller for an implantable heart pump that...

Interested in learning more about how we can work together in your current or next medical device design project?

Just fill out this form and we’ll be in touch!