FDA Devices Inspection Summary – FY 2013

A review of the Inspection Observation Summary for FY2013 was conducted with a focus on inspections of Devices.

From 10-1-12 to 9-30-13 approximately 1099 device 483’s were issued and a total of 4393 citations were referenced.  This is approximately the same number of 483’s that were issued in 2012 (N=1090), however the number of citations referenced in 2013 was approximately 6% lower than 2012 (N=4393 versus N=4660).

The majority of findings as one would expect is within the Quality System Regulation 21 CFR 820 (N=3897).  The next largest group was Medical Device Reporting Regulations 21 CFR 803 , (N=274), followed by Investigational Device Exemption regulations 21 CFR 812 (N=178).  The final two groups with the lowest frequency of citations includes Medical Device Reports of Corrections and Removals 21 CFR 806 (N=41) and Medical Device Tracking 821 CFR 821 (N=4).

Limiting the citations to elements included in 21 CFR 820, the following list identifies the subpart and the frequency of finding for the FY 2013 data:

• Subpart M – Record, 742 citations
• Subpart C – Design Controls, 582 citations
• Subpart G – Production and Process Controls, 555 citations
• Subpart J – Corrective and Preventive Action, 516 citations
• Subpart B – Quality System Requirements, 471 citations
• Subpart H – Acceptance Activities, 258 citations
• Subpart E – Purchasing Controls, 246 citations
• Subpart I – Nonconforming Product, 189 citations
• Subpart D – Document Controls, 155 citations
• Subpart K – Labeling and Packaging Controls, 52 citations
• Subpart L – Handing, Storage, Distribution, and Installation, 46 citations
• Subpart 0 – Statistical Techniques, 40 citations
• Subpart N – Servicing, 36 citations
• Subpart F – Identification and Traceability, 9 citations

The top 5 most frequently cited regulations in 2013 include:

• 21 CFR 820.100(a), with a frequency of 378.  This regulation establishes the requirement for CAPA.
• 21 CFR 820.198(a), with a frequency of 315.  This regulation establishes the requirement for Complaint Files.
• 21 CFR 820.22, with a frequency of 190.  This regulation establishes the requirement for Quality Audits.
• 21 CFR 820.30(g), with a frequency of 177.  This regulation establishes the requirement for Design Validation.
• 21 CFR 820.184, with a frequency of 176.  This regulation establishes the requirement for the Device History Record.