FDA Top 10 Trend Analysis


In a previous post I identified the top 10 USFDA findings for FY 2014 as identified from the FDA Inspection and Observation summary for the Drug Center.  However, this made me wonder if the top 10 findings are consistent with time or do the top 10 findings change over time.

I reviewed the USFDA Drug Center, Inspections and Observation data for 2014 through 2010 to perform a trend analysis, identifying the top 10 findings by frequency for each year.  To visualize the data I used a stacked graph chart the results can be seen below with the data labels and frequency of occurrence within the graph.5-year FDA Data Analysis

Items that ranked in the top 10 for each of the 5 years include:

21 CFR 211.22(d) – Responsibilities of the Quality Control unit was cited 835 times.

21 CFR 211.160(b) – Establishment of scientifically sound and appropriate specs, standards, sampling plans and test procedures was cited 542 times.

21 CFR 211.192 – Production Record Review was cited 577 times.

21 CFR 211.100(a) – Written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess was cited 526 times.

12 CFR 211.67(a) Equipment Cleaning and Maintenance was cited 352 times.

Limiting the analysis to only the 5-year top 10 findings, the above items represent 60% of the total number of citations issued. Based on this limited data set that the top 10 items are relatively consistent year-to-year as the above five items were present in each year, with another three items present in 4 of the 5 years.  Thus 8 items were consistently present in 4 or more of the 5 years measured so in my opinion the top 10 issues do seem to be consistent year-to-year.