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•United States

Argenta US Manufacturing LLC, Shawnee, KS – FDA Inspections

Inspection records and compliance data for Argenta US Manufacturing LLC in Shawnee, Kansas. 12 FDA inspections on record, 4 Form 483s, last inspected September 04, 2026.

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Company Profile

This profile covers Argenta US Manufacturing LLC based in Shawnee, Kansas, United States.

FDA Inspection History

FDA inspections
12
OAI
0
VAI
10
NAI
0
Unclassified
2
Form 483s
4
Warning letters
0

First inspected June 17, 2009. Last inspected September 4, 2026.

Most cited issue areas

  • Procedures for sterile drug products5 inspections
  • SOPs not followed / documented3 inspections
  • Complete test data included in records2 inspections

FDA inspections (12)

DateResultFDA center(s)Insp. #
September 4, 2026Not classifiedAnimal Drugs & Feeds1334734
July 24, 2026Not classifiedAnimal Drugs & Feeds1328088
December 15, 2023VAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance1225274
December 14, 2022VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices1192756
August 1, 2019VAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance1098756
August 15, 2016VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices987003
July 30, 2015VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices936339
November 1, 2013VAIAnimal Drugs & Feeds, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance853861
May 21, 2013VAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices832691
March 8, 2012VAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance771301
June 10, 2010VAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance670469
June 17, 2009VAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance589972
FDA documents

Form 483s (3)

  • Form 483s · December 15, 2023
  • Form 483s · December 14, 2022
  • Form 483s · August 1, 2019

EIRs (1)

  • EIRs · August 1, 2019
People (6)
Alan L. Truong
Person
Marcus F. Yambot
Person
Praveen Hiremath
Person
Joyce Lee
Person
Michael Zubelewicz
Person
Gretchen L. Trendel
Person
Related Companies (10)

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A. Nelson & Co., Ltd.
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Piramal Critical Care, Inc.
Pharmacia & Upjohn Company LLC
DeVere Company, Inc.
Tropichem Research Labs, LLC dba Vetio
Changzhou Pharmaceutical Factory
Pharmaron Shaoxing Co., Ltd
Company Information

Name

Argenta US Manufacturing LLC

FEI Number

1910953

Address

12707 Shawnee Mission Pkwy, Shawnee, Kansas 66216, United States

Country

United States

ID: be369a5c-ac21-4111-897f-1f4983ce11bc

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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