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

Total Inspections: 5

Total 483s Issued: 4

Total Warning Letters Issued: 2

Inspection Details

Longest Inspection: 47 days

Shortest Inspection: 5 days

Average Length of Inspection: 18.2 days

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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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Download 483s and EIRs for 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

Active Locations

Year-wise Inspection Count