Mark E Chan

FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: San Jose CA 95112-7702

Organizations: DHHS FDA ORA OGROP ORA OMPTO OMDRHO DMDRHOIII MDRHCB

Total Inspections: 98

Total 483s Issued: 72

Total Warning Letters Issued: 5

Inspection Details

Longest Inspection: 51 days

Shortest Inspection: 1 days

Average Length of Inspection: 4.6 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2019-05-16Zhejiang Runqiang Medical Instruments Co., Ltd.JiaxingChina3010321647
2019-05-09Shenzhen Jiacom Technology Co., LtdShenzhenChina3011792045
2019-04-18Laser Dental InnovationsSan JoseUnited States3003610527
2019-03-14Cardiva Medical, Inc.Santa ClaraUnited States3015145497
2019-02-15Second Source Medical, LLCSan JoseUnited States3008791915
2019-01-25BAROnova Inc.San CarlosUnited States3012573149
2018-12-21Duke Empirical Inc.Santa CruzUnited States3009906207
2018-02-07Shenzhen Viatom Technology Co., Ltd.ShenzhenChina3011200896
2018-02-01Hongrita Plastics (Shenzhen) Ltd.ShenzhenChina3008374335
2017-12-14Laser Dental InnovationsSan JoseUnited States3003610527

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Download 483s and EIRs for Mark E Chan

Co-Inspectors

NameInspectionsLast Inspection
Mary R Hole22015
Lance M De Souza22012
Lance A Finnical12015
Gene D Arcy12013
Caryn M Mcnab12012
Diane C Van Leeuwen12012
Quynh Strandberg12012
William V Millar12011
Roberta K Smith12010
Peter E Baker12010
Mark A Chen12010
Ashar P Parikh12010
Francis J Eng12009
Alla Dubrovsky12009
Jocelyn T Ramos12009
Sergio Chavez12009
John A Liu12009

Active Locations

Year-wise Inspection Count