Kevin A Gonzalez

FDA Investigator Report

Designation: SUPERVISORY CONSUMER SAFETY

Duty Station: Rockville MD 20857

Organizations: DHHS FDA ORA OGROP ORA OMPTO OPQO DFPQI FPQIBII

Total Inspections: 47

Total 483s Issued: 39

Total Warning Letters Issued: 1

Inspection Details

Longest Inspection: 5 days

Shortest Inspection: 1 days

Average Length of Inspection: 0.9 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2015-05-29Fujian Kerui Pharmaceutical Co., Ltd.FujianChina3003657686
2015-05-29Fujian Kerui Pharmaceutical Co., Ltd.FuzhouChina3004161427
2015-05-22Jiangsu Tianhe Pharmaceutical Co.YangzhouChina3010939885
2015-05-15Jiangxi Guoyao Pharmaceutical, LLC, Co.NanchangChina3002807344
2013-03-14BrightGene Pharmaceutical Co., Ltd.SuzhouChina3009867839
2013-03-07SM Biomed Sdn BhdSungai PetaniMalaysia3005983287
2013-03-01Hamari PFST, Ltd.YonezawaJapan3002808528
2013-01-11Fresenius Kabi USA, LLCGrand IslandUnited States3001833549
2012-10-23Ebewe Pharma Ges.m.b.H.Nfg. KGUnterach am AtterseeAustria3002829723
2012-10-12Sandoz GmbHKundlAustria3002806523

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Download 483s and EIRs for Kevin A Gonzalez

Co-Inspectors

NameInspectionsLast Inspection
Felix Maldonado62011
Javier O Vega32008
James D Bridges22013
Karen L Kosar22013
Demitria J Xiradakis22012
Jose A Lopez Rubet22012
Ginger M Sykes22008
Carla A Norris22008
Susan M Jackson22008
Helen B Ricalde12010
Eric J Reisenauer12010
Karl Auguste12009
Iraida Ortiz12009
Chad N Thompson12009
Alice S Tsao12009

Active Locations

Year-wise Inspection Count