Maria Estrella - FDA Investigator Report

Designation: CSO(PRE APPROVAL MANAGER)

Duty Station: East Brunswick NJ 08816

Organizations: DHHS FDA ORA OGROP ORA OMPTO OPQO DPQOI PQIBI

Overview Statistics

83
Total Inspections
44
Total 483s Issued
0
Warning Letters Issued

Inspection Details

Longest Inspection: 45 days
Shortest Inspection: 1 days
Average Length: 5.2 days

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Maria Estrella's Recent Inspections

DateCompanyCityCountryFEI Number483
2023-06-20GlaxoSmithKline, LLC.ConshohockenUnited States3004055938
2022-12-16Interquim S.A. de C.V.Cuautitlan IzcalliMexico3005170172
2022-12-09Bayer de Mexico, S.A. de C.V.LermaMexico3002806479
2019-08-09Lake Chemicals Private LimitedBangaloreIndia3004513714
2019-08-02Hikal LimitedJiganiIndia3003560263
2019-07-25TCG Lifesciences Private Ltd.KolkataIndia3006627482
2018-10-23ENDO U.S.A Inc.CranburyUnited States2243842
2018-05-22Rakshit Drugs Private LtdHyderabadIndia3009404354
2018-05-16Accrete Pharmaceuticals Private LimitedChoutuppal MandalIndia3011918002
2018-05-10Aurobindo Pharma Limited - Unit 9SangareddyIndia3006370489

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Maria Estrella - Co-Inspectors

NameInspectionsLast Inspection
Michael Serrano52015
Addam S Reynolds52011
Barbara J Wilimczyk-Macri52010
Nicholas A Violand42014
Lauren L Vajo42012
Paul L Bellamy32016
Jennifer Macmillan32011
Atul Agrawal32010
Adetutu M Gidado22023
Alan L Truong22022
Nicole E Knowlton22017
Doreen P Gubbay22011
Jessica M Monteiro22011
Anastasia M Shields12023
Liatte Krueger12015
Sharon K Thoma12015
Dawn L Wydner12011
Lisa M Bellows12011
Kristen E Rescigno12011
Jonee J Mearns12011
Denise M Visco12011
Frederick Razzaghi12010

Maria Estrella's Active Locations

  • United States
  • India
  • Canada
  • Mexico

Maria Estrella's Year-wise Inspection Count

  • 2010:10 inspections
  • 2011:21 inspections
  • 2012:9 inspections
  • 2013:11 inspections
  • 2014:11 inspections
  • 2015:8 inspections
  • 2016:1 inspections
  • 2017:2 inspections
  • 2018:4 inspections
  • 2019:3 inspections
  • 2022:2 inspections
  • 2023:1 inspections
Last Updated: 2025-05-14 06:11:22