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Marian E. Ramirez

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FDA investigator. Took part in 62 inspections of 54 companies, 2016–2026.

Inspections (62)
DateCompanyClassificationProject areaInspection
September 23, 2026Baxter Healthcare CorporationVAIDrug Quality Assurance#1337134
August 11, 2026Alcami Carolinas CorporationNot classifiedDrug Quality Assurance#1330734
July 10, 2026Millicent Manufacturing PR LLCNot classified#1332556
June 10, 2026Abbvie Biotechnology Ltd.Not classifiedDrug Quality Assurance#1321476
May 12, 2026Lilly del Caribe, Inc.Not classified#1321482
April 1, 2026KBI Biopharma, Inc.Not classified#1312108
February 11, 2026Janssen Cilag Manufacturing LLCVAIDrug Quality Assurance#1302416
January 23, 2026Brisas del Caribe, Corp.Not classifiedMonitoring of Marketed Animal Drugs, Feeds, and Devices#1300270
November 7, 2025AIAC International Pharma, LLCNot classifiedDrug Quality Assurance#1290790
October 14, 2025PF Consumer Healthcare BV (Puerto Rico Operations) LLCNot classifiedDrug Quality Assurance#1282192
September 10, 2025MSD International GmbH (Puerto Rico Branch) LLCNot classified#1282038
July 18, 2025Ajinomoto Co. Inc (Kyushu Plant)Not classified#1279738
July 11, 2025Otsuka Pharmaceutical Co., Ltd.Not classified#1279569
July 4, 2025Hisamitsu Pharmaceutical Co., Inc.VAIDrug Quality Assurance#1273761
June 5, 2025Galephar Pharmaceutical Research Inc.NAIDrug Quality Assurance#1273815
May 2, 2025VIANT PUERTO RICO, INCOAIGeneric Drug Evaluation#1268767
March 19, 2025Darmerica, LLCNot classified#1257482
February 7, 2025Hospira, Inc.Not classified#1251941
January 22, 2025Artesanales P.R. LLCOAIDrug Quality Assurance#1239023
November 25, 2024American Injectables IncVAIDrug Quality Assurance#1255204
See all 62 inspections in the dashboard
Documents (50)
  • EIR · Pfizer Pharmaceuticals, LLC · February 17, 2022
  • 483 · Ajinomoto Co. Inc. Kyushu Plant · July 18, 2025
  • 483 · Ajinomoto Co. Inc (Kyushu Plant) · July 14, 2025
  • 483 · Laboratorios Rety de Colombia S A S · December 6, 2019
  • 483 · Viatris Pharmaceuticals LLC · January 26, 2018
  • 483 · Chongqing Southwest No 2 Pharmaceutical Factory Co., Ltd · May 27, 2024
  • 483 · Viatris Pharmaceuticals LLC · February 17, 2022
  • 483 · Gasco Industrial Corp. · December 8, 2023
  • 483 · AIAC International Pharma, LLC · November 7, 2025
  • 483 · PF Consumer Healthcare BV (Puerto Rico Operations) LLC · October 14, 2025
  • 483 · Galephar Pharmaceutical Research Inc. · October 18, 2024
  • 483 · American Injectables Inc · November 25, 2024
  • 483 · Artesanales P.R. LLC · January 22, 2025
  • 483 · VIANT PUERTO RICO, INC · May 2, 2025
  • 483 · NEOLPHARMA, INC. · April 1, 2022
  • 483 · Novo Nordisk Pharmaceutical Industries LP · August 29, 2024
  • 483 · Hisamitsu Pharmaceutical Co., Inc. · July 4, 2025
  • 483 · Uniao Quimica Farmaceutica Nacional SA · August 9, 2023
  • 483 · Lilly del Caribe, Inc · July 9, 2019
  • 483 · Guang'an Kingday Pharma & Chem Co. Ltd. · May 20, 2024
  • 483 · Patheon Puerto Rico, Inc. · July 12, 2022
  • 483 · Amgen Manufacturing Ltd · July 5, 2023
  • 483 · Taro Pharmaceuticals Inc. · September 16, 2022
  • 483 · Janssen Cilag Manufacturing LLC · November 23, 2021
  • EIR · Caribe Holdings (Cayman) Co. Ltd dba PuraCap Caribe · July 2, 2021
  • 483 · Boehringer Ingelheim Animal Health Puerto Rico LLC · March 29, 2019
  • 483 · MSD International GmbH (Puerto Rico Branch) LLC · September 10, 2025
  • 483 · McNeil Healthcare, LLC · September 20, 2023
  • 483 · Omega & Delta Co., Inc. · October 23, 2023
  • 483 · AIAC International Pharma, LLC · June 1, 2018
  • 483 · Frenda Corporation · August 1, 2022
  • 483 · Biomedics Systems Inc · October 4, 2019
  • 483 · Little Moon Essentials LLC · January 18, 2024
  • EIR · MSD International GmbH (Puerto Rico Branch) LLC · February 26, 2020
  • 483 · Caribe Holdings (Cayman) Co. Ltd dba PuraCap Caribe · July 2, 2021
  • EIR · Formulated Solutions, LLC · August 29, 2019
  • 483 · Otsuka Pharmaceutical Co., Ltd. · July 7, 2025
  • 483 · Max Chemical Inc · March 15, 2024
  • 483 · Auro PR Inc · May 31, 2023
  • 483 · Omega & Delta Co., Inc. · May 6, 2022
  • 483 · Brisas del Caribe, Corp. · January 23, 2026
  • 483 · Auro PR Inc · March 15, 2018
  • 483 · Janssen Cilag Manufacturing LLC · February 11, 2026
  • 483 · KBI Biopharma, Inc. · April 1, 2026
  • 483 · Stallion Laboratories Private Limited · March 24, 2023
  • 483 · Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · July 11, 2025
  • 483 · Darmerica, LLC · March 19, 2025
  • 483 · Lilly del Caribe, Inc. · February 17, 2023
  • 483 · MSD International GmbH (Puerto Rico Branch) LLC · February 26, 2020
  • 483 · Abbvie Biotechnology Ltd. · June 10, 2026
Frequently inspected with (10)
Alan A. Rivera
8 shared
Jose F. Velez
8 shared
Yoriann M. Cabrera Bartolomei
7 shared
Angelica M. Hernandez
4 shared
Christian F. Gomez Lugo
4 shared
Mabany Lizardi
4 shared
Jose E. Melendez

Quality System Specialist

3 shared
Damaris Y. Hernandez
2 shared
Dorothy P. Kramer
2 shared
Joan M. Cantellops Figueroa
2 shared
Person Information

Name

Marian E. Ramirez

Title

investigator

Role

COMPANY REP

ID: 4b718b67-fee0-488c-9354-ee366d3510ad

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