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.