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Lauren N. Howard

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FDA investigator. Took part in 40 inspections of 34 companies, 2016–2025.

Inspections (40)
DateCompanyClassificationProject areaInspection
May 30, 2025Micro Labs LimitedVAIDrug Quality Assurance#1271754
May 20, 2025Watson Pharma Private LimitedNot classifiedDrug Quality Assurance#1270737
June 18, 2024Pharmpur GmbhVAIDrug Quality Assurance#1244161
June 7, 2024Sweet Tec GmbHNAIFoodborne Biological Hazards#1245100
June 4, 2024Jahnke Susswaren GmbHNAIDrug Quality Assurance#1242478
April 3, 2024Kindeva Drug Delivery L.P.VAINew Drug Evaluation#1235569
December 8, 2023Patheon Biologics LLCVAIDrug Quality Assurance#1224734
September 15, 2023Wickliffe Pharmaceutical IncOAIMonitoring of Marketed Animal Drugs, Feed, and Devices#1218721
April 7, 2023Teva Womens Health, LLCNAIDrug Quality Assurance#1205874
January 31, 2023AbbVie Inc.VAIMonitoring of Marketed Animal Drugs, Feed, and Devices#1198013
September 19, 2019Bausch Health Companies Inc.NAIDrug Quality Assurance#1108379
September 12, 2019LEC Custom Products, IncVAIDrug Quality Assurance#1103191
August 9, 2019Resilience US, Inc.VAINew Drug Evaluation#1099149
July 29, 2019Allergan Sales LLCVAIUnapproved and Misbranded Drugs#1097944
June 27, 2019Hyalynx IncVAIMonitoring of Marketed Animal Drugs, Feed, and Devices#1094297
May 15, 2019Smithfield Bioscience IncVAIDrug Quality Assurance#1091136
March 5, 2019Universal Packaging Systems, Inc.VAIPostmarket Assurance: Devices#1083347
February 8, 2019Teva Womens Health, LLCNot classifiedGeneric Drug Evaluation#1078871
January 25, 2019Adare Pharmaceuticals, Inc.NAIDrug Quality Assurance#1077858
December 4, 2018LGM Pharma LLCOAIDrug Quality Assurance#1073414
See all 40 inspections in the dashboard
Documents (32)
  • 483 · New Vitalis Pharmacy LLC · August 27, 2021
  • 483 · Infusion Partners, LLC · January 26, 2018
  • 483 · The Medicine Shoppe · September 28, 2022
  • AMENDED 483 · Wickliffe Pharmaceutical Inc · September 15, 2023
  • 483 · TMC Acquisitions LLC · March 14, 2022
  • EIR · Shenzhen Oriental Pharmaceutical Co Ltd · November 29, 2024
  • 483 · Resilience US, Inc. · May 25, 2022
  • 483 · Allergan Sales LLC · June 24, 2021
  • 483 · Patheon Biologics LLC · December 8, 2023
  • 483 · Allergan Sales LLC · July 29, 2019
  • EIR · Xellia Pharmaceuticals USA LLC · January 31, 2020
  • 483 · Micro Labs Limited · May 30, 2025
  • 483 · AbbVie Inc. · January 31, 2023
  • 483 · Watson Pharma Private Limited · May 20, 2025
  • EIR · Allergan Sales LLC · July 29, 2019
  • 483 · CIL Isotope Separations, LLC · January 25, 2022
  • EIR · Patheon Pharmaceuticals Inc. · December 13, 2019
  • 483 · Infusion Partners, LLC · January 26, 2018
  • EIR · Vantage Specialty Ingredients Inc · February 16, 2018
  • 483 · Resilience US, Inc. · August 9, 2019
  • EIR · Adare Pharmaceuticals, Inc. · January 25, 2019
  • 483 · Aldrich Chemical · December 13, 2021
  • 483 · Universal Packaging Systems, Inc. · March 5, 2019
  • 483 · LGM Pharma LLC · December 4, 2018
  • 483 · Smithfield Bioscience Inc · July 15, 2022
  • EIR · Smithfield Bioscience Inc · July 15, 2022
  • EIR · Aldrich Chemical · December 13, 2021
  • 483 · Miami University · November 5, 2021
  • 483 · Smithfield Bioscience Inc · May 15, 2019
  • 483 · Kindeva Drug Delivery L.P. · April 3, 2024
  • EIR · Allergan Sales LLC · June 24, 2021
  • EIR · Patheon Pharmaceuticals Inc. · January 14, 2020
Frequently inspected with (10)
Lindsey S. Fleischman

issuing_officer

4 shared
Heather A. McCauley

Director of Investigations Branch 2

2 shared
Jazmine N. Brown
2 shared
Jon P. Antoniou
2 shared
Lianji Jin

investigator

2 shared
Mary B. Sheets

Investigator

2 shared
Tamil Arasu

Consumer Safety Officer - Dedicated Foreign Drug Cadre

2 shared
Teresa K. Kastner
2 shared
Allison A. Aldridge
1 shared
Andrew J. Barrowcliff
1 shared
Person Information

Name

Lauren N. Howard

Title

Drug Specialist

Role

Regulatory Personnel

ID: 538f77fe-b977-49c9-a5b3-289cf8a6e886

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