Biometrics and Data Analysis in FDA's Regulatory Inspections

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 • 131 82845B – Full QSIT • 30 82845C – Compliance Inspection • 29 82845A – Abbreviated QSIT • 25 82845G – For Cause • 22 82845S – Sterile Device • 145 81001 – MDR • 25 81845R – Corrections/Removals

21. Enforcement Trends

22. What’s New?