The 2017 FY FDA inspection summary has been published to the FDA website. you may download the FY 2017 Excel File from the following link. This file contains a summary of FDA Form 483 data for inspections ending between 10/1/2016 and 9/30/2017 and is a great tool to evaluate the various citations observed from various FDA inspections. The below summary identifies the number of 483’s issued by center, and each data page lists the citations per the corresponding code section.
The FDA identified 3,206 citations referenced to specific sections of 21 CFR 210 and 211. Approximately 25% of the citations are attributable to 6 sections of the code:
The FDA identified 3,515 citations referenced to specific sections of 21 CFR 820. Approximately 50% of the citations are attributable to 9 sections of the code:
A common shortcoming observed in the Medical Device industry are observations relating to Medical Device Reporting (MDR) 21 CFR 803. These regulations can be located at the following link. According to the FY 2017 FDA Inspection Summary, there were 250 observations attributed to Medical Device Reporting with a majority referenced to lack or MDR procedures. A distribution of citations is provided below:
In summary, many people comment on the value of big data. Ideally the ability to gain insights, and an advantage, from analysis of large data sets with respect to how this information may relate back to your industry. FDA has provided free data sets of inspection data from FY 2006 to FY 2017, this represents 11-years of data available for download and analysis. This data can provide bench-marking on recent inspection trends, or evaluate how inspection trends have shifted over time. If the inspection trends identify a specific focus/short coming within one of the FDA regulated industries, wouldn’t it be great to be proactive and evaluate if this condition exists within your facility?