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Compliance Activities 2006 New England District Office FDA

Compliance Activities 2006 New England District Office FDA. CAPT Mutahar Shamsi, USPHS Director, Compliance Branch mutahar.shamsi@fda.hhs.gov. Top 5 Device 483 Cites 2003 - 2006 . 21CFR820.198(a), maintain Complaint files 21CFR820.100(a), establish Corrective & preventive action procedures

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Compliance Activities 2006 New England District Office FDA

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  1. Compliance Activities2006New England District OfficeFDA CAPT Mutahar Shamsi, USPHS Director, Compliance Branch mutahar.shamsi@fda.hhs.gov MSS 01DEC06

  2. Top 5 Device 483 Cites2003 - 2006 • 21CFR820.198(a), maintain Complaint files • 21CFR820.100(a), establish Corrective & preventive action procedures • 21 CFR 803.17, written MDR procedures • 21CFR820.75(a), Process validation • 21CFR820.100(b), document Corrective & preventive action • 21CFR820.22, Quality audit procedures; Management w/ executive responsibility(2005) MSS 01DEC06

  3. 2006 Top 5 NWE-DO Device 483 Cites • 21CFR820.22, Quality audit • 21CFR820.25(b), Training documentation • 21CFR820.198(a), maintain Complaint files • 21CFR820.100(b), document Corrective & preventive action • 21CFR820.100(a), establish Corrective & preventive action MSS 01DEC06

  4. 2005 Top 5 NWE-DO Device 483 Cites • 21CFR820.100(b), document Corrective & preventive action • 21CFR820.198(a), maintain Complaint files • 21CFR820.22, Quality audit • 21CFR820.100(a) establish Corrective & preventive action MSS 01DEC06

  5. 2005 Top 5 NWE-DO Device 483 Cites • 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 MSS 01DEC06

  6. 2006 NWE-DO Device Cites by Section • Corrective & preventive action • Quality audit • Complaint files • Medical Device Reporting • Personnel; Receiving, in-process, & finished device acceptance MSS 01DEC06

  7. 2005 NWE-DO Device Cites by Section • Corrective & preventive action • Complaint files • Receiving, in-process, & finished device acceptance • Production & process controls • Medical Device Reporting MSS 01DEC06

  8. Summary 483’s MSS 01DEC06

  9. Actions • 1 Seizure • Unapproved device • Did not meet performance standard • Mislabeled • Unregistered facility MSS 01DEC06

  10. Actions • 3 Warning Letters • Corporate – wide • Recidivist • QSR + MDR + Corrections & Removals MSS 01DEC06

  11. Actions • Imports • Detained • Examination gloves (GMPs, holes) • Bandages (GMPs) • Xray equipment (no 510(k)) • UV lamp (no accession #) • Refused • Examination gloves (holes) MSS 01DEC06

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