1. Metric, Data and Analysis Biometrics Ricki A. Chase Director, Investigations Branch ricki.chase@fda.hhs.gov 312-596-4240

2. Center Work Planning District Work Planning Factors Driving Frequency Unplanned Work Data What’s New

3. Center Work Planning (CDER) –Process and Communication between CDER and ORA –CDERs Risk Model –Assignments to the field Focus on change management Compounding Pharmacies

4. Factors of CDER’s Risk Model (Top Level) –Product Dosage Form Intrinsic Chemical Properties –Facility Poor GMP Compliance History –Process Measuring Mixing Compression Filling

5. Top Ranked High Risk Product Categories –Biotech –Liquid Sterile Solution –Liquid Sterile Suspension/Emulsion –MDI low active –MDI high active

6. Poor Compliance History Recalls FARs Warning Letters/Recidivist Under Consent Decree Failure to obtain application

7. Process Factors Contamination Yield Changeover Cleanability Validation Maintenance

8. District Work Plan (CDER)

9. Center Work Planning (CDRH) –District Driven Process –Special Coverage Requests to the Field Data driven directed inspections

10. CDRH Special Factors Class 1 Inspection Initiative –Increase number of recalls –Inconsistencies in device registration/listing –Better use of resources

11. District Decision Factors Statutory Requirement to Inspect Classification of Device Compliance History MDRs and Recalls Industry Trends

12. Unplanned Work Recalls 6 months post regulatory action FARs/MDRs Directed Inspection Request Pre-approvals Consumer Complaints

13. Recalls

14. Recall Activities

16. Pharma Observation Trends QCU Production/Process Control – not followed Lab Controls Batch Discrepancies No P/PC 21 CFR 211.22(d) 21 CFR 211.100(b) 21 CFR 211.160(b) 21 CFR 211.192 21 CFR 211.100(a)

17. Pharma Inspectional Specifics 2013 537 Total Inspections Classified OAI –81 56002 – Drug Manufacturing –69 56002A – Sterile Drugs –20 56002F – API –6 56002H – Abbreviated Drug EI –5 56002B – Drug Repackers/Relabelers

18. Device Observation Trends CAPA Procedures MDR Procedures CAPA Activities Process Validation Complaint Handling 21 CFR 820.100(a) 21 CFR 803.17 21 CFR 820.100(b) 21 CFR 820.75(a) 21 CFR 820.198(a)

19. Device Inspectional Specifics 2013 537 Total Inspections Classified OAI –13182845B – Full QSIT –3082845C – Compliance Inspection –29 82845A – Abbreviated QSIT –2582845G – For Cause –2282845S – Sterile Device –14581001 – MDR –2581845R – Corrections/Removals

21. Enforcement Trends

22. What’s New?