Meeting and maintaining FDA compliance standards can be a challenge for even the most seasoned organization. Receiving a form 483 as a result of an inspection is common and is often expected. There are several common causes of FDA 483 that, with a few simple good manufacturing practices (GMPs), an organization could avoid. EMMA International can work with organizations to help avoid these common pitfalls.

One of the most common pitfalls that an organization might fall into is not properly following procedures. Written SOPs play a large role in any organization, especially life science or health care organization. If an SOP becomes out of date or if an SOP is up to date but employees do not follow it accurately, then this would be a violation of regulatory requirements. Procedures should be standardized throughout the entire organization to ensure that every department meets FDA compliance and prevents a 483. For medical devices, the FDA found almost 500 violations related to procedures in 2020[1].

Another common reason for an FDA 483 is the failure to investigate discrepancies1. The FDA requires an investigation into every incident, failure to do so will result in a violation. Conducting corrective and preventative actions (CAPAs) so that the same incident does not occur again in the future will help to ensure continued regulatory compliance.

While the first two common pitfalls that result in a 483 are a little more involved, some things can often go unnoticed that will result in a 483.  Improperly cleaning and sanitizing workspace, improper environmental monitoring, even having food or drink in the wrong place can result in a noncompliance1. EMMA international can help to avoid these pitfalls and maintain FDA compliance. From developing a quality management system to assisting with regulatory submissions, EMMA can help bring your medical product from concept to commercialization. Give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (Nov 2020) Inspection Observations retrieved on 10/04/2021 from: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/inspection-observations

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

Ready to learn more about working with us?

Pin It on Pinterest

Share This