Xiaohui Shen - FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CDER OMPT CDER OC OMQ DDQI GCBI

Overview Statistics

5
Total Inspections
4
Total 483s Issued
2
Warning Letters Issued

Inspection Details

Longest Inspection: 47 days
Shortest Inspection: 5 days
Average Length: 18.2 days

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Xiaohui Shen's Recent Inspections

DateCompanyCityCountryFEI Number483
2023-08-25Central Admixture Pharmacy Services IncSan DiegoUnited States3004378804
2019-04-05Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyBristolUnited States3014877770
2017-03-31Amphastar Pharmaceuticals, Inc.Rancho CucamongaUnited States3002936358
2016-10-14Granules India LimitedMedchal-Malkhajgiri DistrictIndia3004097901
2016-03-18Baxter Oncology GmbHHalle (Westf.)Germany3002806419

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Xiaohui Shen - Co-Inspectors

NameInspectionsLast Inspection
Rachel C Stanton12023
Doan N Singh12023
Jolanna A Norton12023
June P Page12019
Jennifer M Gogley12017
Amir Alavi12017
Walden H Lee12017
Amanda L Fyles12017
Marcus F Yambot12017
Carrie A Hughes12017
Sonya L Karsik12017
Jeffrey P Raimondi12017
Zhihao Pete Qiu12016
Steven P Donald12016
Roger F Zabinski12016
Michael A Charles12016

Xiaohui Shen's Active Locations

  • United States
  • India
  • Germany

Xiaohui Shen's Year-wise Inspection Count

  • 2016:2 inspections
  • 2017:1 inspections
  • 2019:1 inspections
  • 2023:1 inspections
Last Updated: 2025-05-14 06:11:22