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•United States

AGC Biologics, Inc., SE and 22021 20th Ave, SE – FDA Inspections

Inspection records and compliance data for AGC Biologics, Inc. in SE and 22021 20th Ave, SE. 9 FDA inspections on record, 5 Form 483s, last inspected April 18, 2025.

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Company Profile

This profile covers AGC Biologics, Inc. based in SE and 22021 20th Ave, SE, United States.

FDA Inspection History

FDA inspections
9
OAI
0
VAI
3
NAI
3
Unclassified
3
Form 483s
5
Warning letters
0

First inspected February 13, 2009. Last inspected April 18, 2025.

FDA inspections (9)

DateResultFDA center(s)Insp. #
April 18, 2025Not classifiedBiologics1265749
March 27, 2024Not classifiedHuman Drugs1231895
February 10, 2023VAIHuman Drugs · Drug Quality Assurance1197098
July 23, 2021VAIBiologics · Blood and Blood Products1149254
October 15, 2018VAIBiologics · Blood and Blood Products1109813
April 20, 2017Not classifiedBiologics1016289
May 15, 2015NAIHuman Drugs · Drug Quality Assurance930335
April 18, 2012NAIBiologics · Blood and Blood Products779103
February 13, 2009NAIHuman Drugs · Drug Quality Assurance562746
FDA documents

Form 483s (9)

  • Form 483s · April 18, 2025
  • Form 483s · March 27, 2024
  • Form 483s · February 10, 2023
  • Form 483s · February 10, 2023
  • Form 483s · July 12, 2021
  • Form 483s · March 19, 2021
  • Form 483s
  • Form 483s
  • Form 483s

EIRs (5)

  • EIRs · July 23, 2021
  • EIRs · March 19, 2021
  • EIRs · October 15, 2018
  • EIRs · May 15, 2015
  • EIRs · April 18, 2012
People (6)
Arie C. Menachem
Person
Colleen Hoyt
Person
Lisa A. Eberle
Person
Andy Walker
Person
Brian Janelins
Person
Charles Luan-Chia Kuo, Staff Fellow
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Rentschler Biopharma Inc.
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Zhejiang Peptites Biotech Co.,Ltd.
Tianjin Asymchem Pharmaceuticals Co., Ltd.
Polpharma Biologics S.A
BIOTECHPHARMA BIOTECHNOLOGINES FARMACIJOS CENTRAS UAB
NOVAVAX CZ
Zydus Lifesciences Limited
Biogen International GmbH
Daiichi Sankyo Chemical Pharma Co., Ltd.
Company Information

Name

AGC Biologics, Inc.

FEI Number

3000209996

Address

21511 23rd Dr., SE and 22021 20th Ave, SE Bothell, United States

Country

United States

ID: 9759f733-dd5f-4f2e-a516-f1b37fad39e2

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Contact
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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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