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 If an SOP becomes out of date or if an SOP is up to date but employees do not follow it accurately, then this would be a violation of regulatory requirements.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.

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