Walden H Lee

FDA Investigator Report

Designation: CHEM(INVESTIGATIVE ANALYST)

Duty Station: Irvine CA 92612

Organizations: DHHS FDA ORA OGROP ORA ORS OMPTSLO PSMPL

Total Inspections: 79

Total 483s Issued: 63

Total Warning Letters Issued: 4

Inspection Details

Longest Inspection: 71 days

Shortest Inspection: 1 days

Average Length of Inspection: 9.3 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2024-09-25Mentha & Allied Products Private Ltd.RampurIndia3004293613
2024-09-12Shree Jaya LaboratoriesNalgondaIndia3011845012
2024-06-28Bachem Americas, Inc.TorranceUnited States2024023
2024-06-06Jubilant HollisterStier LLCSpokaneUnited States3010477
2024-05-10PolyPeptide Laboratories, Inc.TorranceUnited States1000519239
2024-03-20Genentech, Inc.South San FranciscoUnited States2917293
2024-03-01Amphastar Pharmaceuticals, Inc.Rancho CucamongaUnited States3002936358
2024-02-09Nephron Sc IncWest ColumbiaUnited States3010892830
2023-12-18Med-Pharmex, Inc.PomonaUnited States2023614
2023-10-27Abbott Vascular IncTemeculaUnited States2024168

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Download 483s and EIRs for Walden H Lee

Co-Inspectors

NameInspectionsLast Inspection
Daniel J Roberts72013
Amanda L Fyles62019
Uttaniti Limchumroon52024
Amir Alavi52021
Linda Thai42024
Christopher R Czajka42024
Minh D Phan42011
Rochelle B Young42008
Michael T Cyrus32024
Joey V Quitania32024
Bryan A Galvez32023
Jolanna A Norton32022
Jennifer M Gogley32019
Carrie A Hughes32018
Jessica L Pressley32017
Nicole E Knowlton32015
Jennifer L Gustavus32014
Uduak M Inokon32010
Nicholas L Hunt22024
Santos E Camara22024
Santiago Gallardo Johnson22022
Teresa I Navas22020
Jose E Melendez22019
Linda F Murphy22019
Yvesna C Blaise22019
Cassandra L Abellard22017
Marcus F Yambot22017
Sonya L Karsik22017
Jose R Lopez22016
Jennifer H Rhyu22014
Ashar P Parikh22014
Kim L Thomas Cruse22013
Jay-Ar C Bendo12024
Anney Lin12024
Homero W Aguilar12024
Andrew Le12024
Rachel C Stanton12024
Lillian S Wu12024
Gunneet Kaur12024
Matthew R Clabeaux12024
Crystal Monroy12024
Michael Araneta12024
David J Gomes12024
Michael S Budziak12024
Kellia N Hicks12024
Yvins Dezan12024
Roger F Zabinski12024
Darren S Brown12024
Juanj Wu12023
Sandra A Boyd12021
Joel D Hustedt12021
Thomas J Arista12021
Sangeeta M Khurana12021
Nayan J Patel12020
Alan L Truong12019
Diane R Weidley12019
Cynthia Jim12019
Saundrea A Munroe12019
Kristin M Abaonza12019
Zachary A Bogorad12019
Adam R Cooke12019
Michael D Kawalek12018
Christopher M Reed12018
Michael S Call12018
Ka L Wong12018
Zachery L Miller12018
Kevin Lee12018
Evelyn Wong12018
Christopher M Jenner12018
Theresa Kirkham12017
Xiaohui Shen12017
Jeffrey P Raimondi12017
Lance A Finnical12016
Arie Menachem12016
Jai P Singh12016
William J Leonard12015
Sharon K Thoma12013
Barbara J Breithaupt12011
Kristy A Zielny12009
Lloyd D Payne12009
Alicia M Mozzachio12009
Binh T Nguyen12008

Active Locations

Year-wise Inspection Count