Jennifer M Gogley

FDA Investigator Report

Designation: MICROBIOLOGIST

Duty Station: Irvine CA 92612

Organizations: DHHS FDA ORA OGROP ORA ORS OMPTSLO PSMPL

Total Inspections: 58

Total 483s Issued: 48

Total Warning Letters Issued: 3

Inspection Details

Longest Inspection: 25 days

Shortest Inspection: 1 days

Average Length of Inspection: 6.7 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2019-11-22Ajinomoto Althea, Inc.San DiegoUnited States3004575449
2019-10-18Huons Co., Ltd. - Jecheon FactoryJecheonKorea (the Republic of)3007163376
2019-05-14Gilead Sciences, Inc.La VerneUnited States3013189568
2019-03-26McGuff Pharmaceuticals, Inc.Santa AnaUnited States2022073
2019-01-25Opto-Pharm Pte Ltd.SingaporeSingapore3005320466
2019-01-18Amgen Singapore Manufacturing Pte LtdSingaporeSingapore3011255424
2018-03-12PrimaPharma IncSan DiegoUnited States1000135880
2017-11-02Nitto Avecia Pharma Services, Inc.IrvineUnited States3012971227
2017-03-31Amphastar Pharmaceuticals, Inc.Rancho CucamongaUnited States3002936358
2017-03-31McGuff Pharmaceuticals, Inc.Santa AnaUnited States2022073

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Co-Inspectors

NameInspectionsLast Inspection
Caryn M Mcnab232015
Carla J Lundi92016
Joey V Quitania52019
Uttaniti Limchumroon52019
Jamie M Du42014
Walden H Lee32019
Anastasia M Shields32019
Marcus F Yambot32017
Virgilio F Pacio32013
James R Fleckenstein32013
Nayan J Patel22019
Amir Alavi22017
Sonya L Karsik22017
Jocelyn E Massey22015
Stephen D Brown22015
Evelyn Wong22015
Binh T Nguyen22013
Shannon B Ruelle22012
John A Gonzalez22011
Kim L Thomas Cruse22010
Margaret M Annes22010
Megan A Haggerty22008
Alan L Truong12019
Diane R Weidley12019
Kristin M Abaonza12019
Bryan A Galvez12019
Seneca D Toms12019
Jolanna A Norton12017
Xiaohui Shen12017
Yvins Dezan12017
Linda Thai12017
Amanda L Fyles12017
Yasamin Ameri12017
Carrie A Hughes12017
Jeffrey P Raimondi12017
Chelsea N Sealey12016
Nabeela J Chaudhry12014
Matthew J Johnson12013
Dejon N Harris12013
Sean P Desbrow12013
Bichsa T Tran12012
Keith P Iams12011
Greg K Keshishyan12011
Angele C Smith12010
Maria C Fermin12010
Allen F Hall12010
Comyar Shoghi12010
Diane C Van Leeuwen12010
Nelly N Tran12009
Pal S Mayasandra12009
Kelvin X Sanders12008

Active Locations

Year-wise Inspection Count