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Maria Estrella

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FDA investigator. Took part in 11 inspections of 11 companies, 2017–2026.

Inspections (11)
DateCompanyClassificationProject areaInspection
January 30, 2026Safrel Pharmaceuticals LLCNot classified#1300468
June 20, 2023GlaxoSmithKline, LLC.NAIDrug Quality Assurance#1211050
August 9, 2019Lake Chemicals Private LimitedOAIDrug Quality Assurance#1099634
August 2, 2019Hikal LimitedVAIDrug Quality Assurance#1105799
July 25, 2019TCG Lifesciences Private Ltd.NAIDrug Quality Assurance#1106616
October 23, 2018ENDO Pharmaceuticals Solutions, Inc.VAIDrug Quality Assurance#1069481
May 22, 2018Rakshit Drugs Private LtdNot classified#1064444
May 16, 2018Accrete Pharmaceuticals Private LimitedNot classified#1056853
May 10, 2018Apitoria Pharma Private LimitedNAIDrug Quality Assurance#1063274
March 10, 2017Alkem Laboratories LimitedVAIDrug Quality Assurance#1007598
March 1, 2017Zydus Lifesciences LimitedNAIDrug Quality Assurance#1007281
Documents (9)
  • EIR · ISP Sutton Laboratories · September 1, 2011
  • 483 · L'Oreal USA Products Inc · December 4, 2012
  • 483 · Accrete Pharmaceuticals Private Limited · May 16, 2018
  • EIR · Hovione LLC · December 16, 2015
  • 483 · Bayer de Mexico, S.A. de C.V. · December 9, 2022
  • 483 · ENDO Pharmaceuticals Solutions, Inc. · October 23, 2018
  • 483 · Hikal Limited · August 1, 2019
  • 483 · Lake Chemicals Private Limited · August 5, 2019
  • 483 · Safrel Pharmaceuticals LLC · January 30, 2026
Frequently inspected with (6)
Adetutu M. Gidado
2 shared
Nicole E. Knowlton

Investigator

2 shared
Anastasia M. Shields

Consumer Safety Officer

1 shared
Dhaval H. Patel
1 shared
James R. Birkenstamm
1 shared
Suchan Kim
1 shared
Person Information

Name

Maria Estrella

Title

investigator

Role

COMPANY REP

ID: 36cf1d7d-41af-4f40-9de4-174a82a31a56

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