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•United States

Chemisphere Corporation, Saint Louis, MO – FDA Inspections

Inspection records and compliance data for Chemisphere Corporation in Saint Louis, Missouri. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected June 24, 2025.

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Company Profile

This profile covers Chemisphere Corporation based in Saint Louis, Missouri, United States.

FDA Inspection History

FDA inspections
5
OAI
1
VAI
3
NAI
1
Form 483s
1
Warning letters
0

First inspected April 5, 2010. Last inspected June 24, 2025.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Cleaning/maintenance records not kept1 inspection
  • Component identification test1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
June 24, 2025OAIHuman Drugs · Drug Quality Assurance1276805
March 17, 2020VAIHuman Drugs · Drug Quality Assurance1122817
May 8, 2015NAIFoods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance926167
September 16, 2011VAIFoods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Compliance: Devices743248
April 5, 2010VAIHuman Drugs, Medical Devices & Rad Health · Drug Quality Assurance655435
FDA documents

Form 483s (2)

  • Form 483s · June 24, 2025
  • Form 483s · March 17, 2020

EIRs (1)

  • EIRs · March 17, 2020
People (5)
Alan M. Roberts
Person
Garrett Smith
Person
Carl A. Huffman
Person
Eric D. Bowles
Person
Mary L. Schuckmann
Person
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Company Information

Name

Chemisphere Corporation

FEI Number

1000158477

Address

2101 Clifton Ave, Saint Louis, Missouri 63139, United States

Country

United States

ID: 60ff2ab3-c198-4dea-ab82-539d7bf5fbc0

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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
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🇪🇺+48 532-447-507
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