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Theresa Kirkham

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FDA investigator. Took part in 14 inspections of 14 companies, 2016–2018.

Inspections (14)
DateCompanyClassificationProject areaInspection
January 19, 2018Yantai Dongcheng Biochemicals Co., Ltd.NAIDrug Quality Assurance#1041347
January 12, 2018Zhuhai Sheencolor Biotech Co., Ltd.VAIDrug Quality Assurance#1041215
December 7, 2017I. Shay Cosmetics IncOAIDrug Quality Assurance#1034137
October 27, 2017University Rx Specialist, dba University Compounding PharmacyNot classifiedDrug Quality Assurance#1030757
September 22, 2017Sterigenics US LLCNAICompliance: Devices#1031318
June 30, 2017Zhejiang Greenface Housewares Co., LtdVAIDrug Quality Assurance#1024198
June 23, 2017Shenzhen Senton Science & Technology Co.,Ltd.OAIDrug Quality Assurance#1022401
May 25, 2017Biofilm, Inc.VAICompliance: Devices#1014535
April 28, 2017Sparsha Pharma Usa IncOAICompliance: Devices#1010514
March 31, 2017ImprimisRx CA, Inc., dba ImprimisRxNot classifiedDrug Quality Assurance#1010017
March 6, 2017Invivoscribe Technologies, Inc.NAIPostmarket Assurance: Devices#1006006
December 16, 2016Haupt Pharma Latina SrlVAIDrug Quality Assurance#1004993
December 8, 2016Lusys Laboratories, Inc.Not classifiedCompliance: Devices#994366
December 6, 2016Sintetica S.A.VAIDrug Quality Assurance#1002397
Documents (5)
  • 483 · University Rx Specialist, dba University Compounding Pharmacy · October 27, 2017
  • EIR · Beckman Coulter Inc. · October 30, 2019
  • 483 · Pacira Pharmaceuticals, Inc. · July 22, 2015
  • 483 · Gram Laboratories Inc · September 4, 2015
  • 483 · ImprimisRx CA, Inc., dba ImprimisRx · March 31, 2017
Frequently inspected with (10)
Constance Y. Fears

issuing_officer

2 shared
Santiago Gallardo Johnson

https://www.fda.gov/media/120628/download

2 shared
Cassandra L. Abellard

investigator

1 shared
Freddy D. Tita-Nwa
1 shared
Marcus F. Yambot

Senior Consumer Safety Officer

1 shared
Roger F. Zabinski

Investigator

1 shared
Rumany C. Penn

Compliance Officer

1 shared
Scott K. Zika
1 shared
Shaquenta Y. Perkins
1 shared
Sonya L. Karsik
1 shared
Person Information

Name

Theresa Kirkham

ID: c7d8aad0-d162-4fac-a1ba-4649c36fd714

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