1. MSS 01DEC06 1 Compliance Activities 2006 New England District Office FDA CAPT Mutahar Shamsi, USPHS Director, Compliance Branch mutahar.shamsi@fda.hhs.gov

2. MSS 01DEC062 Top 5 Device 483 Cites 2003 - 2006 Top 5 Device 483 Cites 2003 - 2006 1. 21CFR820.198(a), maintain Complaint files 2. 21CFR820.100(a), establish Corrective & preventive action procedures 3. 21 CFR 803.17, written MDR procedures 4. 21CFR820.75(a), Process validation 5. 21CFR820.100(b), document Corrective & preventive action 5. 21CFR820.22, Quality audit procedures; Management w/ executive responsibility(2005)

3. MSS 01DEC063 2006 Top 5 NWE-DO Device 483 Cites 1. 21CFR820.22, Quality audit 2. 21CFR820.25(b), Training documentation 3. 21CFR820.198(a), maintain Complaint files 4. 21CFR820.100(b), document Corrective & preventive action 5. 21CFR820.100(a), establish Corrective & preventive action

4. MSS 01DEC064 2005 Top 5 NWE-DO Device 483 Cites 1. 21CFR820.100(b), document Corrective & preventive action 2. 21CFR820.198(a), maintain Complaint files 3. 21CFR820.22, Quality audit 4. 21CFR820.100(a) establish Corrective & preventive action

5. MSS 01DEC065 2005 Top 5 NWE-DO Device 483 Cites 5. 21CFR820.25(b) establish Training procedures; 21CFR803.50(a)(2), MDRs malfunctions; 21CFR820.100(b), document Corrective & preventive action; 21CFR820.198(a)(3), MDR evaluation

6. MSS 01DEC066 2006 NWE-DO Device Cites by Section 1. Corrective & preventive action 2. Quality audit 3. Complaint files 4. Medical Device Reporting 5. Personnel; Receiving, in-process, & finished device acceptance

7. MSS 01DEC067 2005 NWE-DO Device Cites by Section 1. Corrective & preventive action 2. Complaint files 3. Receiving, in-process, & finished device acceptance 4. Production & process controls 5. Medical Device Reporting

8. MSS 01DEC068 Summary 483s FDA – Wide 2003 - 2006 NWE-DO CitesSections 2006200520062005 198(a)22100(b) CAPA (100) 100(a)25(b)198(a) Quality Audit (22) Complaints (198) 803.17198(a)22 Recv (80) 75(a)100(b)100(a) MDRs (803) P&PC (70) 100(b)/ 22 (2005) 100(a) 25(b),803. 50(a)(2),1 00(b)198(a )(3) Recv (80); Personnel (25) MDRs (803)

9. MSS 01DEC069 Actions 1 Seizure 1 Seizure Unapproved device Unapproved device Did not meet performance standard Did not meet performance standard Mislabeled Mislabeled Unregistered facility Unregistered facility

10. MSS 01DEC0610 Actions 3 Warning Letters 3 Warning Letters 1.Corporate – wide 2.Recidivist 3.QSR + MDR + Corrections & Removals

11. MSS 01DEC0611 Actions Imports Imports Detained Detained Examination gloves (GMPs, holes) Examination gloves (GMPs, holes) Bandages (GMPs) Bandages (GMPs) Xray equipment (no 510(k)) Xray equipment (no 510(k)) UV lamp (no accession #) UV lamp (no accession #) Refused Refused Examination gloves (holes) Examination gloves (holes)