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  5. Shawn E. Larson
FDA Person
•Office of Medical Products and Tobacco Operations

Shawn E. Larson

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FDA investigator, Office of Medical Products and Tobacco Operations. Took part in 21 inspections of 21 companies, 2016–2026.

Inspections (21)
DateCompanyClassificationProject areaInspection
February 10, 2026Kenvue Brands LLCVAIDrug Quality Assurance#1298966
November 6, 2025Morton Salt, Inc.Not classified#1288354
March 13, 2025Amgen, Inc.VAIDrug Quality Assurance#1256132
May 31, 2023Amware Fulfillment LLCNAIDrug Quality Assurance#1208205
June 28, 2019Pharmalogic South Carolina LLCVAIDrug Quality Assurance#1094674
September 22, 2017Amgen Technology (Ireland) Unlimited CompanyVAIDrug Quality Assurance#1026365
September 12, 2017Ipsen BioPharm LtdVAIDrug Quality Assurance#1026364
August 4, 2017Alcon Research LLCVAIDrug Quality Assurance#1021656
June 30, 2017Beauty Manufacturing Solutions Corp.OAIDrug Quality Assurance#1016639
May 18, 2017Chemolee Lab CorporationVAIDrug Quality Assurance#1014340
April 20, 20173D Imaging Drug Design and DevelopmentOAIDrug Quality Assurance#1009371
April 7, 2017Analytical Food Laboratories Inc.VAIDrug Quality Assurance#1006798
March 10, 2017ICU Medical IncVAIDrug Quality Assurance#1009809
February 3, 2017Amerisource BergenNAIMonitoring of Marketed Animal Drugs, Feed, and Devices#1000864
February 2, 2017Reliant Holding, Ltd.NAIDrug Quality Assurance#1000724
January 31, 2017Reliant Processing, LtdVAIDrug Quality Assurance#1000723
January 20, 2017Select CorporationVAIDrug Quality Assurance#998846
December 15, 2016CareFusion 213, LLCVAINew Drug Evaluation#997744
November 22, 2016ABC Compounding Company of Texas, Inc.NAIDrug Quality Assurance#996002
November 4, 2016BioTE MedicalOAIFood Composition, Standards, Labeling and Econ#991397
See all 21 inspections in the dashboard
Documents (17)
  • WARNING LETTER · King Bio Inc. · July 20, 2018
  • WARNING LETTER · North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding · March 10, 2022
  • 483 · MOORE'S PHARMACY INC · September 1, 2016
  • UNTITLED LETTER · Davis City Pharmacy Inc. · February 17, 2022
  • STATE REFERRAL LETTER · Promise Pharmacy, LLC · August 30, 2021
  • STATE REFERRAL LETTER · Peoples Pharmacy, Inc. · November 28, 2017
  • STATE REFERRAL LETTER · Pacifico National, Inc. dba AmEx Pharmacy · April 15, 2019
  • STATE REFERRAL LETTER · MCALISTER DRUG CORPORATION · September 23, 2019
  • STATE REFERRAL LETTER · Dougherty's Pharmacy · June 19, 2019
  • 483 · Qualgen, LLC · September 17, 2015
  • 483 · Morton Salt, Inc. · November 6, 2025
  • 483 · Biocon Sdn. Bhd. (Company No. 201101002193) · February 21, 2020
  • 483 · Amgen, Inc. · March 13, 2025
  • 483 · Kindeva Drug Delivery Limited · August 12, 2016
  • 483 · Alcon Research LLC · August 4, 2017
  • 483 · Pharmalogic South Carolina LLC · June 28, 2019
  • 483 · Kenvue Brands LLC · February 10, 2026
Frequently inspected with (10)
Margaret M. Annes
3 shared
Susan T. Hadman

Microbiologist

2 shared
Anh Lac
1 shared
Elizabeth R. Bloom
1 shared
Gabriel Bermudez-Picart

investigator

1 shared
June P. Page
1 shared
Junho Pak

Investigator

1 shared
Michael T. Cyrus

Microbiologist

1 shared
Nimmy Mathews

Regulatory Project Manager

1 shared
Rodney L. Tinzie
1 shared
Related Office
Office of Medical Products and Tobacco Operations
Person Information

Name

Shawn E. Larson

Title

Development Coordinator

Office

Office of Medical Products and Tobacco Operations

Role

Regulatory Personnel

ID: a3515e47-60a3-48ff-b27c-f79bd03db12b

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