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•United States

KBI Biopharma, Inc., Boulder, CO – FDA Inspections

Inspection records and compliance data for KBI Biopharma, Inc. in Boulder, Colorado. 3 FDA inspections on record, 2 Form 483s, last inspected December 03, 2021.

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Company Profile

This profile covers KBI Biopharma, Inc. based in Boulder, Colorado, United States.

FDA Inspection History

FDA inspections
3
OAI
0
VAI
1
NAI
0
Unclassified
2
Form 483s
2
Warning letters
0

First inspected December 9, 2016. Last inspected December 3, 2021.

FDA inspections (3)

DateResultFDA center(s)Insp. #
December 3, 2021VAIHuman Drugs · Drug Quality Assurance1158021
September 12, 2018Not classifiedHuman Drugs1066025
December 9, 2016Not classifiedHuman Drugs994318
FDA documents

Form 483s (2)

  • Form 483s · December 3, 2021
  • Form 483s · March 2, 2020

EIRs (2)

  • EIRs · December 3, 2021
  • EIRs · March 6, 2020
Other regulators (1)
  • UK MHRA · 1 inspection · last July 31, 2017
People (5)
Erika V. Butler
Person
Sandra Lueken
Person
Genoula K. Ryan
Person
Michael A. Charles
Person
Nicholas L. Hunt
Person
Related Companies (10)

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Zydus Lifesciences Limited
PharmaEssentia Corporation, Taichung Plant
Wuxi Biologics Co Ltd
Daito Pharmaceutical Co., Ltd.
WuXi Biologics Ireland Limited
ANTHEM BIOSCIENCES PRIVATE LIMITED - Phase II
Regeneron Ireland Designated Activity Company
FUJIFILM Diosynth Biotechnologies Texas, LLC
Company Information

Name

KBI Biopharma, Inc.

FEI Number

3011326133

Address

2500 Central Ave, Boulder, Colorado 80301, United States

Country

United States

ID: 0116f415-95dd-4a3f-a854-182d0314d5a5

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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
info@keypedia.com
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