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Andrew Le

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FDA investigator. Took part in 42 inspections of 42 companies, 2023–2026.

Inspections (42)
DateCompanyClassificationProject areaInspection
September 23, 2026PETNET Solutions IncNAIDrug Quality Assurance#1340798
September 22, 2026PETNET SOLUTIONS, INC.NAIDrug Quality Assurance#1340138
September 17, 2026Precision Nuclear LLCVAIDrug Quality Assurance#1336184
August 28, 2026SOCIETAL CDMO SAN DIEGO, LLCNot classifiedDrug Quality Assurance#1333550
August 4, 2026Air Products and Chemicals, IncNAIDrug Quality Assurance#1331688
July 30, 2026Sterigenics U.S., LLCNot classifiedDrug Quality Assurance#1328800
July 16, 2026Air Products And Chemicals IncNot classified#1330202
July 15, 2026Linde Inc.NAIDrug Quality Assurance#1327750
July 14, 2026Airgas USA LLCNAIDrug Quality Assurance#1327776
June 30, 2026Carlsbad Technology, IncNot classifiedDrug Quality Assurance#1324410
December 17, 2025Macau-Union Pharmaceutical LimitedOAIDrug Quality Assurance#1300178
December 12, 2025Hovione PharmaScience LimitedNot classified#1298568
December 5, 2025Shandong Jincheng Kunlun Pharmaceutical Co., Ltd.Not classified#1297680
November 21, 2025B. Braun Medical IncOAIDrug Quality Assurance#1292536
September 26, 2025Petnet Solutions Inc.VAIDrug Quality Assurance#1284422
September 24, 2025Mayo Clinic PET Radiochemistry FacilityVAIDrug Quality Assurance#1283146
September 19, 2025Barbara Ann Karmanos Cancer HospitalVAIDrug Quality Assurance#1282496
September 17, 2025Division of Nuclear Medicine PET Radiopharmaceutical Production ProgramOAIDrug Quality Assurance#1282498
September 10, 2025AMPAC Fine Chemicals LLCNot classified#1288220
September 5, 2025PETNET SOLUTIONS, INC.VAIDrug Quality Assurance#1280733
See all 42 inspections in the dashboard
Documents (34)
  • 483 · Wedgewood Connect, LLC · November 17, 2023
  • 483 RESPONSE · Wedgewood Connect, LLC · November 17, 2023
  • EIR · Novartis Gene Therapies, Inc. · February 15, 2019
  • EIR · PETNET Solutions, Inc · June 15, 2022
  • 483 · Mayo Clinic PET Radiochemistry Facility · September 24, 2025
  • 483 · Petnet Solutions Inc. · September 26, 2025
  • 483 · Division of Nuclear Medicine PET Radiopharmaceutical Production Program · September 17, 2025
  • 483 · Sofie Co. · September 3, 2025
  • 483 · RMLC Industries LLC dba Mr. Lulu LLC · December 9, 2022
  • 483 · Mayo Clinic PET Radiochemistry Facility · September 24, 2025
  • 483 · B. Braun Medical Inc · November 21, 2025
  • 483 · UCSF Radiopharmaceutical Facility · July 24, 2025
  • 483 · Private Label Partners, Inc. · January 17, 2025
  • 483 · Barbara Ann Karmanos Cancer Hospital · September 19, 2025
  • 483 · Beckman Research Institute, City of Hope · August 20, 2025
  • 483 · ACTA Laboratories, Inc. · February 13, 2023
  • 483 · Orange Lab Holdings · September 21, 2023
  • EIR · Merck & Company · January 20, 2021
  • 483 · Westwood Laboratories, LLC. · October 31, 2024
  • 483 · Aurobindo Pharma Ltd · July 21, 2023
  • 483 · Silgan Unicep Packaging Llc · June 14, 2024
  • 483 · PETNET SOLUTIONS, INC. · September 5, 2025
  • 483 · Sun Pharmaceutical Medicare Limited · July 13, 2023
  • 483 · Yusef Manufacturing Laboratories, LLC · November 4, 2022
  • 483 · Puremedy Inc. · February 12, 2024
  • 483 · Bhargava Phytolab Private Limited · July 26, 2024
  • 483 · Dr. Brite LLC · April 5, 2024
  • 483 · PolyPeptide Laboratories, Inc. · May 10, 2024
  • 483 · Divi's Laboratories Ltd. (Unit II) · July 19, 2024
  • 483 · Clean Cosmetics, LLC · August 19, 2022
  • 483 · Kari Gran Inc. · July 8, 2022
  • 483 · Macau-Union Pharmaceutical Limited · December 17, 2025
  • 483 · Carlsbad Technology, Inc · June 30, 2026
  • 483 · SOCIETAL CDMO SAN DIEGO, LLC · August 28, 2026
Frequently inspected with (10)
Ngozi G. Offor

issuing_officer

6 shared
Gloria E. Andia
5 shared
Navneet Kaur
5 shared
Thuy Tram L. Nguyen
5 shared
Anney Lin

Statistical Science Director

4 shared
Darren S. Brown

Consumer Safety Officer

4 shared
Khoa Nathan V. Tran

issuing_officer

4 shared
Lillian S. Wu
4 shared
Tareq W. Haddad
4 shared
Anastasia M. Shields

Consumer Safety Officer

2 shared
Person Information

Name

Andrew Le

Title

Regulatory Affairs Specialist

Role

Regulatory Personnel

ID: 573464c0-de29-4f64-ab33-62543b7fe719

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