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Anastasia M. Shields

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FDA investigator. Took part in 86 inspections of 82 companies, 2016–2026.

Inspections (86)
DateCompanyClassificationProject areaInspection
September 4, 2026Nippon Kayaku Pharmatech Co., Ltd.Not classifiedDrug Quality Assurance#1335048
August 4, 2026KVK Tech, Inc.Not classifiedDrug Quality Assurance#1329488
July 15, 2026GlaxoSmithKline, LLC.Not classified#1332910
June 18, 2026Copperhead Chemical Company, Inc.Not classified#1328046
April 24, 2026Oxalis LabsNot classifiedDrug Quality Assurance#1314606
April 17, 2026Cipla LimitedNot classifiedDrug Quality Assurance#1313374
January 29, 2026Apotek Production & Laboratorier ABNot classifiedNew Drug Evaluation#1301488
January 20, 2026Charles River Laboratories, Inc.NAIDrug Quality Assurance#1303694
November 21, 2025Sato Pharmaceutical Co., Ltd.OAIDrug Quality Assurance#1292356
November 11, 2025Fukuzyu Pharmaceutical Co., Ltd.Not classified#1295338
October 16, 2025Medical Products Laboratories, Inc.Not classifiedDrug Quality Assurance#1277039
September 17, 2025Quotient Sciences - Philadelphia, LLCVAIDrug Quality Assurance#1282368
September 2, 2025PETNET Solutions, Inc.Not classifiedDrug Quality Assurance#1286966
July 11, 2025Sumitomo Dainippon Pharma Co., Ltd.VAIDrug Quality Assurance#1276963
July 1, 2025Shionogi Pharma Co., Ltd.OAIDrug Quality Assurance#1275087
June 5, 2025Catalent Pharma Solutions, LLCNAIDrug Quality Assurance#1275086
May 9, 2025Abbey Color IncorporatedNot classified#1269877
March 28, 2025ONESOURCE SPECIALTY PHARMA LIMITEDVAIDrug Quality Assurance#1265787
March 19, 2025Amneal Pharmaceuticals Private LimitedNot classifiedDrug Quality Assurance#1264196
February 7, 2025WuXi Advanced TherapiesNAIDrug Quality Assurance#1262215
See all 86 inspections in the dashboard
Documents (79)
  • 483 · Baxter Pharmaceuticals India Pvt Ltd · August 26, 2016
  • 483 · EUGIA Pharma Specialities Limited · March 6, 2018
  • 483 · Zydus Lifesciences Limited · April 23, 2024
  • 483 · NATCO Pharma Limited · January 24, 2017
  • EIR · Almac Pharma Services LLC · February 3, 2022
  • 483 · Akom Pharmaceuticals, Inc. · June 10, 2016
  • 483 · Eugia Pharma Specialities Limited · February 2, 2024
  • EIR · Packaging Coordinators, LLC · October 21, 2022
  • 483 · Sato Pharmaceutical Co., Ltd. · November 13, 2025
  • 483 · Gland Chemicals Private Limited · August 7, 2018
  • 483 · Fukuzyu Pharmaceutical Co., Ltd. · November 11, 2025
  • EIR · Quotient Sciences - Philadelphia, LLC · December 22, 2022
  • 483 · Biological E. Limited · November 12, 2024
  • 483 · PETNET Solutions, Inc. · September 2, 2025
  • 483 · Quotient Sciences - Philadelphia, LLC · September 17, 2025
  • 483 · Sumitomo Dainippon Pharma Co., Ltd. · July 11, 2025
  • 483 · Shionogi Pharma Co., Ltd. · July 1, 2025
  • 483 · Amneal Pharmaceuticals Private Limited · March 19, 2025
  • 483 · Quotient Sciences - Philadelphia, LLC · December 22, 2022
  • 483 · Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil · September 16, 2022
  • 483 · Fisher Pharmaceuticals Ltd. · July 28, 2022
  • 483 · Akom Pharmaceuticals, Inc.
  • 483 · Wild Child Laboratories Pty Ltd. · June 21, 2024
  • 483 · Steriscience SP. Z O.O. · April 28, 2023
  • 483 · Indoco Remedies Limited · February 28, 2023
  • 483 · Frontida BioPharm Inc · December 7, 2023
  • 483 · Frontage Laboratories, Inc. · January 10, 2025
  • EIR · Calumet Karns City Refining LLC · August 2, 2016
  • 483 · Straight Arrow Products, Inc. · October 15, 2024
  • 483 · Abbey Color Incorporated · May 9, 2025
  • 483 · ONESOURCE SPECIALTY PHARMA LIMITED · March 28, 2025
  • 483 · Gland Chemicals Private Limited
  • EIR · Zydus Lifesciences Limited · April 23, 2024
  • 483 · Opto-Pharm Pte Ltd. · January 25, 2019
  • EIR · JOHNSON AND JOHNSON CONSUMER INC MCNEIL CONSUMER HEALTHCARE DIV · May 3, 2021
  • 483 · Nectar Lifesciences Limited · March 10, 2023
  • 483 · Dercher Enterprises, Inc., DBA Gordon Laboratories · September 20, 2023
  • 483 · Homeocare Laboratories, Inc. · June 4, 2021
  • 483 · Aurobindo Pharma Ltd · July 21, 2023
  • 483 · AstraZeneca Pharmaceuticals LP · January 19, 2023
  • 483 · Mylan Laboratories Limited · May 27, 2022
  • 483 · Sun Pharmaceutical Medicare Limited · July 13, 2023
  • 483 · Sato Pharmaceutical Co., Ltd. · November 21, 2025
  • EIR · Siegfried (Nantong) Pharmaceuticals Co., Ltd. · August 16, 2019
  • 483 · Alphapharm Pty, Ltd. · June 28, 2024
  • 483 · EUGIA Pharma Specialities Limited · May 3, 2024
  • 483 · Corden Pharma Bergamo SPA · June 17, 2016
  • 483 · Medical Products Laboratories, Inc. · October 16, 2025
  • 483 · Holodiag · March 23, 2022
  • 483 · Keybio · March 11, 2022
  • 483 · Almac Pharma Services LLC · February 3, 2022
  • 483 · WuXi Advanced Therapies · April 17, 2015
  • 483 · Boiron Inc. · October 25, 2021
  • 483 · Baxter Pharmaceuticals India Pvt Ltd · May 17, 2022
  • 483 · Homeocare Laboratories, Inc. · December 13, 2019
  • 483 · Packaging Coordinators, LLC · October 21, 2022
  • 483 · Moehs Catalana SL · May 18, 2018
  • 483 · Washington Homeopathic Products, Inc. · August 19, 2021
  • 483 · Amneal Oncology Private Limited · March 15, 2018
  • 483 · Ungerer & Co · June 5, 2024
  • 483 · Fresenius Kabi Oncology Limited · October 10, 2023
  • 483 · Brassica Pharma Private Ltd · January 19, 2024
  • 483 · ACS Dobfar SPA (Plant #2) · July 18, 2017
  • 483 · Johnson & Johnson Consumer, Inc · March 24, 2021
  • 483 · Washington Homeopathic Products, Inc. · July 2, 2019
  • 483 · Kilitch Healthcare India Limited · October 20, 2023
  • 483 · PharmaGend Global Medical Services Pte. Ltd. · February 1, 2019
  • 483 · Velocity Pharma LLC · December 14, 2023
  • 483 · National Chemical Laboratories · May 26, 2023
  • 483 · Steriscience Specialties Private Limited · November 22, 2024
  • 483 · Apotek Production & Laboratorier AB · January 29, 2026
  • 483 · Cipla Limited · April 17, 2026
  • 483 · Copperhead Chemical Company, Inc. · June 18, 2026
  • 483 · API Solutions Inc. · May 27, 2026
  • EIR · WuXi Advanced Therapies · April 17, 2015
  • 483 · Oxalis Labs · April 24, 2026
  • 483 · Rohto Pharmaceutical Co., Ltd. (Ueno Plant) · August 25, 2026
  • 483 · Nippon Kayaku Pharmatech Co., Ltd. · September 4, 2026
  • 483 · GlaxoSmithKline, LLC.
Frequently inspected with (10)
Justin A. Boyd

Research Specialist II

6 shared
Christina K. Theodorou

Consumer Safety Officer

5 shared
Linda F. Murphy

SVP Consulting & Operations

4 shared
Jeffrey P. Raimondi

Consumer Safety Officer

3 shared
Lu Chen

Investigator

3 shared
Samina S. Khan
3 shared
Adena S. Yau
2 shared
Alan A. Rivera
2 shared
Andrew Le

Regulatory Affairs Specialist

2 shared
Bijoy Panicker
2 shared
Person Information

Name

Anastasia M. Shields

Title

Consumer Safety Officer

Role

Regulatory Personnel

ID: a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df

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