Audit 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.
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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:
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)
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)
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)
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)
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, si