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•United States

Kashiv BioSciences, LLC, Chicago, IL – FDA Inspections

Inspection records and compliance data for Kashiv BioSciences, LLC in Chicago, Illinois. 6 FDA inspections on record (1 OAI), 4 Form 483s, last inspected September 04, 2026.

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Company Profile

This profile covers Kashiv BioSciences, LLC based in Chicago, Illinois, United States.

FDA Inspection History

FDA inspections
6
OAI
1
VAI
2
NAI
0
Unclassified
3
Form 483s
4
Warning letters
0

First inspected February 9, 2015. Last inspected September 4, 2026.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Approve or reject components, products1 inspection
  • Component identity verification1 inspection

FDA inspections (6)

DateResultFDA center(s)Insp. #
September 4, 2026Not classifiedHuman Drugs, Medical Devices & Rad Health · Generic Drug Evaluation1298244
June 14, 2024VAIHuman Drugs · Drug Quality Assurance1241763
March 12, 2019Not classifiedHuman Drugs1083905
January 26, 2018OAIHuman Drugs · Drug Quality Assurance1038740
November 21, 2017Not classifiedHuman Drugs1039357
February 9, 2015VAIHuman Drugs · Drug Quality Assurance914031
FDA documents

Form 483s (6)

  • Form 483s · June 14, 2024
  • Form 483s · November 21, 2022
  • Form 483s · January 14, 2022
  • Form 483s · March 12, 2019
  • Form 483s · January 22, 2018
  • Form 483s · November 21, 2017

EIRs (3)

  • EIRs · March 12, 2019
  • EIRs · November 21, 2017
  • EIRs · February 9, 2015

Other FDA documents (2)

  • Other FDA documents
  • Other FDA documents
People (5)
Vaishali J. Patel
Person
Rong Wang
Person
Rebecca E. Dombrowski
Person
Nibin Varghese
Person
Anders Evenson
Person
Related Companies (10)

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

SUNNY PHARMTECH INC.
Exela Pharma Sciences LLC
Shanghai Henlius Biologics Co., Ltd.
Par Formulations Private Limited
Akeso Biopharma Co., Ltd.
Hugel Inc.
Samsung Biologics Co., Ltd.
Berkshire Sterile Manufacturing, LLC
Advanced Accelerator Applications USA, Inc.
IDT Biologika GmbH
Company Information

Name

Kashiv BioSciences, LLC

FEI Number

3011289655

Address

3440 S Dearborn St Ste 300, Chicago, Illinois 60616, United States

Country

United States

ID: 4e1d54cb-33c0-4bda-85e8-95cc306e2f33

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