The most common FDA 483 observations

Aaron Hoare Date published: Apr 18, 23

We are often asked what the most common FDA 483 observations are. As many organizations see it, the first step towards avoiding citation themselves is to understand what the most common violations are. There is definitely merit to this approach.

So, we have looked at the data to give you a top 10 list of the most common FDA 483 observations to help you better avoid them in your own organization and to help you maintain the highest standards of quality.

The FDA carries out inspections in a number of industries. For this article, we are predominantly focusing on the most common FDA 483 observations in the Medical Device and Drug (Pharmaceutical) industries. The raw data containing the results for other industries – such as Foods or Bioresearch Monitoring – is available on the FDA website.

What is FDA 483?

FDA 483 is a form used by the United States Food and Drug Administration (FDA) during inspections of regulated facilities to document any observations of potential non-compliance with FDA regulations. The name "FDA 483" refers to the specific section of the Food, Drug, and Cosmetic Act that authorizes FDA inspectors to conduct inspections and collect evidence of violations.

If an FDA inspector observes any deviations from the regulations, they will document their findings on the FDA 483 form. This will be provided to the facility management at the end of the inspection. It’s important to note that this form is not a formal notice of violation. Rather, it is a list of observations made during the inspection, which may indicate potential areas of concern.

The FDA 483 form serves as a tool to assist regulated facilities in understanding and correcting potential compliance issues, and as a starting point for communication between the FDA and the facility. Regulated facilities are expected to respond to the observations on the FDA 483 form in writing within 15 working days, providing explanations for any deviations and outlining corrective actions to be taken.

What are the most common FDA 483 observations?

Many FDA 483 observations are similar, overlapping, or essentially the same observation just applied to different areas of your operation. We have taken care to consider this when selecting our top 10 most common types of observation, which are:

1. Inadequate or insufficient documentation of procedures, testing, or quality control measures. E.g. Cite ID 1105, Ref number 21 CFR 211.22(d) – Procedures not in writing, fully followed (241 observations since 2021)
2. Inadequate training of personnel in relevant procedures or quality control measures. E.g. Cite ID 2350, Ref Number 21 CFR 820.25(b) – Training – Lack of or Inadequate Procedures (55 observations since 2021)
3. Inadequate or insufficient investigation or correction of deviations or complaints. E.g. Cite ID 14713, Ref Number 21 CFR 820.198(a) – lack of or inadequate complaint procedures (187 observations since 2021)
4. Failure to follow established procedures or protocols. E.g. Cite ID 1358, Ref Number 21 CFR 211.100(b) – SOPs not followed/documented (39 observations since 2021)
5. Equipment or facility deficiencies that could affect the safety or quality of products. E.g. Cite ID 1177, Ref Number 21 CFR 211.63 – Equipment design, size and location (85 observations since 2021)
6. Lack of or inadequate validation of processes or equipment. E.g. Cite ID 1452, Ref Number 21 CFR 211.113(b) – Validation lacking for sterile drug products (44 observations since 2021)
7. Inadequate or insufficient testing of products or raw materials. E.g. Cite ID 1883, Ref Number 21 CFR 211.165(a) – Testing and release for distribution (54 observations since 2021)
8. Failure to properly handle, store, or label materials. E.g. Cite ID 1790, Ref Number 21 CFR 211.80(b) – Handling and storage to prevent contamination (8 observations since 2021)
9. Failure to establish or maintain adequate records or logs. E.g. Cite ID 3160, Ref Number 21 CFR 820.184 – Lack of or inadequate DHR procedures (38 observations since 2021)
10. Failure to properly report adverse events or incidents. E.g. Cite ID 732, Ref Number 21 CFR 803.50(a) (2) – Individual report of malfunction (24 observations since 2021)

Please note: the specific citations listed above are examples of different types/categories of citation. There are alternative examples of specific citations that fit each category, but we wanted to provide a single example citation for each category.

So, while there have only been 8 citations for “handling and storage to prevent contamination,” there are several other citations that fit the observation category: 8 – failure to properly handle, store, or label materials. When these similar citations are grouped together, handling and storage is a much bigger issue than the 8 occurrences of a single citation type suggests.

How to avoid FDA 483 citations 

To avoid FDA 483 citations, it is important to maintain a culture of quality that prioritizes compliance throughout your organization. Here are some steps you can take to achieve this:

1. Develop and maintain a robust quality system: Ensure that you have a well-documented quality system that covers all aspects of your operations. This should include standard operating procedures (SOPs), training programs, and documentation practices.
2. Effectively manage the training and development of your people: Ensure that your people are trained on the relevant regulations and standards, and that they understand their role in maintaining compliance.
3. Conduct internal audits: Regularly conduct internal audits of your facility and operations to identify and address potential compliance issues before they become a problem.
4. Monitor and control your supply chain: Ensure that your suppliers and vendors meet the same quality standards as your own operations, and that you have appropriate controls in place to monitor their performance.
5. Respond appropriately to any issues that arise: If an issue is identified during an inspection, take prompt action to address it and ensure that corrective actions are documented and implemented.

By following these steps, you can help ensure that your facility maintains compliance with regulations and avoids FDA 483 citations.

Using powerful QMS software to avoid FDA 483 citations

An effective quality management system can help you avoid all of the most common FDA 483 observations. And the most effective quality management systems make use of powerful QMS software.

Ideagen QMS solutions provide all the tools for maintaining compliance and instilling the culture of quality in your organization that will prevent FDA 483 observations.

Our five tips to avoid FDA 483 observations above? Our software gives you the tools to implement each step. And on those rare occasions when an FDA inspection still results in 483 observations, our software can be used to get you back on track to compliance in no time.

Book a demo or a call with our team so we can guide you towards the right solution for avoiding FDA 483 citations when your next inspection is due.

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