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.
2017 FY FDA Inspection Summary:
Analysis of 2017 FY FDA Inspection Summary from CDER:
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:
- 21 CFR 211.192 – Production Record Review – 193 citations 6.02% of the total
- 21 CFR 211.22(d) – Organization and Personnel, Responsibilities of the Quality Control Unit – 185 citations, 5.77% of the total
- 21 CFR 211.160(b) – Laboratory Controls, General Requirements – 124 citations, 3.87% of the total
- 21 CFR 211.100(a) – Production and Process Controls, Written Procedures Deviations – 116 citations, 3.62% of the total
- 21 CFR 211.25(a) – Organization and Personnel, Personnel Qualifications – 113 citations, 3.52% of the total
- 21 CFR 211.113(b) – Production and Process Controls, Control of Microbial Contamination – 92 citations, 2.87% of the total
Analysis of 2017 FY FDA Inspection Summary from CDRH (Devices):
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:
- 21 CFR 820.100 (a) and (b) – Corrective and Preventive Action (a) 400 citations, (b) 115 citations – 515 combined and 14.65% of the total
- 21 CFR 820.198(a) – Records, Complaint Files – 323 citations, 9.19% of the total
- 21 CFR 820.75(a) – Production and Process Controls, Process Validation – 165 citations 4.69% of the total
- 21 CFR 820.30(g) – Design Controls, Design Validation – 164 citations, 4.67% of the total
- 21 CFR 820.90(a) – Nonconforming product – 161 citations, 4.58% of the total
- 21 CFR 820.184 – Records, Device History Records – 146 citations, 4.15% of the total
- 21 CFR 820.22 – Quality System Requirements, Quality Audits – 141 citations, 4.01% of the total
- 21 CFR 820.50 – Purchasing Controls – 138 citations, 3.93% of the total.
Analysis of 2017 FY FDA Inspection Summary from CDRH (MDR):
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?