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Tonia F. Bernard

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FDA investigator. Took part in 73 inspections of 73 companies, 2016–2026.

Inspections (73)
DateCompanyClassificationProject areaInspection
June 25, 2026PCI Laboratories Co., LtdNot classified#1326616
June 5, 2026The United Laboratories (Inner Mongolia) Co. Ltd.Not classified#1323624
May 8, 2026Beijing Yiling Bio-engineering Technology Co., Ltd.Not classified#1319170
March 26, 2026Shandong Excel Pharmaceutical Co., Ltd.Not classified#1313372
March 20, 2026Bath Concepts Cosmetics (Dongguan) Co., Ltd.Not classified#1312404
January 16, 2026HUTCHMED Limited (Shanghai plant)Not classified#1304144
November 6, 2025Sichuan Huiyu Pharmaceutical Co., Ltd.Not classified#1300108
September 11, 2025Beijing Biotech-Pack Scientific Co., Ltd.Not classified#1287326
September 5, 2025Chongqing Kangle Pharmaceutical Co., LtdNot classified#1286254
June 13, 2025Shenzhen Hepalink Pharmaceutical Group Co., Ltd.Not classified#1276175
May 14, 2025Shanghai Applied Protein Technology Co., Ltd.Not classified#1276173
April 25, 2025Shandong Haiyan Medical Manufacture Co., Ltd.Not classified#1273010
March 31, 2025SINO MEDICAL SCIENCES TECHNOLOGY INC.Not classified#1265312
March 7, 2025Wuxi Apptec Suzhou Co.,LtdNot classified#1264869
February 14, 2025Huiqiang Sun HuangNot classified#1262423
January 14, 2025CCIC Huatongwei International Inspection (Suzhou) Co., Ltd.Not classified#1259499
November 8, 2024Lights Medical Manufacture Co LtdNot classified#1258804
July 29, 2024Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)Not classified#1250164
April 26, 2024BrightGene Pharmaceutical Co., Ltd.VAIDrug Quality Assurance#1240231
March 29, 2024Jilin Shengtong Chemical Co., Ltd.Not classified#1236094
See all 73 inspections in the dashboard
Documents (41)
  • EIR · SGS Analytics Germany GmbH · October 30, 2019
  • 483 · Athenex Pharma Solutions, LLC · August 28, 2019
  • 483 · Millers of Wyckoff, Inc. · October 9, 2020
  • 483 · QuVa Pharma, Inc. · November 30, 2017
  • 483 · Colonia Care Pharmacy · April 22, 2019
  • 483 · PharmScript, LLC · October 24, 2016
  • 483 · Intergel Pharmaceuticals, LLC · November 20, 2018
  • EIR · Avantor Inc. · August 12, 2019
  • 483 · Wuxi STA Pharmaceutical Co., Ltd · March 3, 2023
  • 483 · Grant Industries, Inc. · August 21, 2020
  • 483 · Sichuan Huiyu Pharmaceutical Co., Ltd. · November 6, 2025
  • 483 · Lights Medical Manufacture Co Ltd · November 8, 2024
  • 483 · Zhejiang Peptites Biotech Co.,Ltd. · September 7, 2023
  • 483 · Huiqiang Sun Huang · February 14, 2025
  • EIR · Azurity Pharmaceuticals, Inc. · July 26, 2019
  • EIR · Wuxi STA Pharmaceutical Co., Ltd · March 3, 2023
  • 483 · Jiyu Wen · September 22, 2023
  • 483 · Hangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co., Ltd · August 19, 2022
  • 483 · Xiamen LP Pharmaceutical Co., Ltd. · March 4, 2022
  • 483 · Shandong Anxin Pharmaceutical Co., Ltd. (Laoling site) · January 13, 2023
  • 483 · James Alexander Corp. · February 27, 2019
  • 483 · Hetero USA Inc · March 17, 2017
  • 483 · Pharmaceutics International Inc · March 24, 2017
  • 483 · Shanghai STA Pharmaceutical Product Co., Ltd. · October 22, 2021
  • 483 · Wuxi Apptec Suzhou Co.,Ltd
  • 483 · Davion Inc · May 15, 2019
  • EIR · Grant Industries, Inc. · August 21, 2020
  • 483 · Intergel Pharmaceuticals, LLC · November 20, 2018
  • 483 · Nippon Fine Chemical Co., Ltd. · June 11, 2019
  • 483 · Alcami Corporation · August 23, 2016
  • EIR · Acupac Packaging Inc · December 17, 2018
  • 483 · Sichuan Qingmu Pharmaceutical Co., Ltd · September 7, 2021
  • 483 · Waterstone Pharmaceuticals Co., Ltd. · September 29, 2021
  • 483 · Jiangxi Bioman Pharma Limited · July 30, 2022
  • 483 · Chifeng Pharmaceutical Company, Ltd. · January 19, 2024
  • 483 · Lights Medical Manufacture Co Ltd · April 5, 2024
  • EIR · Cispharma Inc. · November 12, 2010
  • 483 · Yabao Pharmaceutical Co., Ltd. Beijing · April 20, 2022
  • 483 · Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) · July 29, 2024
  • 483 · CCIC Huatongwei International Inspection (Suzhou) Co., Ltd. · January 14, 2025
  • 483 · Shanghai Institute of Measurement and Testing Technology Co., Ltd. · July 23, 2026
Frequently inspected with (10)
Janete F. Guardia
3 shared
Zakaria I. Ganiyu

Investigator

2 shared
Andrew R. Wasko
1 shared
Chaltu N.Wakijra

Senior Program Coordinator

1 shared
Dawn C. Olenjack
1 shared
Emmanuel J. Ramos

Compliance Officer at FDA

1 shared
Guerlain Ulysse

Investigator

1 shared
Jose M. Cayuela
1 shared
Lata C. Mathew
1 shared
Liatte K. Closs
1 shared
Person Information

Name

Tonia F. Bernard

ID: 607c8dae-63cb-491a-8d7d-ddfa0ee1b67d

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