Michael D Kawalek

FDA Investigator Report

Designation: MICROBIOLOGIST

Duty Station: Irvine CA 92612

Organizations: DHHS FDA ORA OGROP ORA ORS OFFLO PSFFL MB

Total Inspections: 13

Total 483s Issued: 8

Total Warning Letters Issued: 1

Inspection Details

Longest Inspection: 81 days

Shortest Inspection: 1 days

Average Length of Inspection: 18.5 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2024-11-01Reser's Fine Foods, Inc. dba Fresh Creative FoodsVistaUnited States1000135693
2024-10-24Reser's Fine Foods, Inc. dba Fresh Creative FoodsVistaUnited States1000135693
2024-05-23Central Valley Cheese, Inc.TurlockUnited States3003780256
2021-09-17High Quality Organics, Inc.RenoUnited States3008497552
2019-11-22Prolacta Bioscience IncCity Of IndustryUnited States3005190793
2019-10-18Shadow Holdings DBA Bocchi LabsSanta ClaritaUnited States1000125317
2019-05-13Montalvan's Sales, Inc.OntarioUnited States3000050474
2018-06-07Shadow Holdings DBA Bocchi LabsSanta ClaritaUnited States1000125317
2013-09-06Allergan Sales, LLC dba Bioscience LaboratoriesCampbellUnited States3000720089
2012-10-15Superstat CorporationRancho DominguezUnited States3001452136

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Co-Inspectors

NameInspectionsLast Inspection
Cristina Resendiz-Navarrete22024
Tuan D Tran22024
Geoffrey M Leist22024
Trusten J Robles12024
Justin M Runac12024
Joseph C Yen12024
Jorge L Bertran12021
Elaine S Chow12021
Victoria L Morgan12021
Sandra M Tallent12019
Claudia M Perez-Kasmarski12019
James A Barreto12019
Greg K Keshishyan12019
Rocio Guzman-Velazquez12019
Elizabeth P Mayer12019
Patricia F Alberico12019
Michael S Call12018
Ka L Wong12018
Zachery L Miller12018
Amir Alavi12018
Walden H Lee12018
Kevin Lee12018
Amanda L Fyles12018
Carrie A Hughes12018
Uduak M Inokon12013
Stephanie A Slater12013
Yvette M Lacour-Davis12012
John C Ho12009
Mei-Chen Mu12009
Norman Wong12009
Durell L Giles12009
Thao T Kwan12009
Sundy Ven12009
Juanita Banuelos12009
Marcus F Yambot12009
Lilly O Barton12009
Sonya L Karsik12009

Active Locations

Year-wise Inspection Count