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Michael E. Maselli

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FDA investigator. Took part in 8 inspections of 8 companies, 2016–2023.

Inspections (8)
DateCompanyClassificationProject areaInspection
March 8, 2023Rohto Pharmaceutical Co., Ltd. (Ueno Plant)VAIDrug Quality Assurance#1202841
February 25, 2023Toyobo Co. Ltd.VAIDrug Quality Assurance#1201609
September 23, 2019Isotopia Molecular Imaging Ltd (Soreq Site)VAINew Drug Evaluation#1102462
September 11, 2019Peer Pharm Ltd.VAIDrug Quality Assurance#1101629
July 31, 2019VIDAL EXPORTACIONES S.A.DE C.V.VAIFoodborne Biological Hazards#1101505
May 4, 2018F. Hoffmann - La Roche Ltd.VAIDrug Quality Assurance#1051581
April 24, 2018F. Hoffmann-La Roche AGNAIDrug Quality Assurance#1055453
November 15, 2016Hetero Labs Ltd. Unit VIOAIDrug Quality Assurance#999209
Documents (4)
  • 483 · Toyobo Co. Ltd. · February 22, 2023
  • EIR · Sage Products, LLC · September 1, 2016
  • 483 · Recipharm Monts · June 9, 2015
  • 483 · Rohto Pharmaceutical Co., Ltd. (Ueno Plant) · March 8, 2023
Frequently inspected with (7)
Anita Narula

Compliance Officer - CDER/OC/OMQ

2 shared
Michele Perry-Williams

Investigator

2 shared
Rachael A. Moss
2 shared
Daniel J. Gorski
1 shared
Janete A. Oliveira
1 shared
Kevin T. Gerrity

National Food Expert

1 shared
Yasamin Ameri

Compliance Officer

1 shared
Person Information

Name

Michael E. Maselli

Title

investigator

Role

COMPANY REP

ID: 84b393a9-864c-4150-a636-d4ee4a60c8af

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