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•United States

Hydrox Chemical Company Inc, Elgin, IL – FDA Inspections

Inspection records and compliance data for Hydrox Chemical Company Inc in Elgin, Illinois. 9 FDA inspections on record, 1 Form 483, last inspected July 25, 2025.

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Company Profile

This profile covers Hydrox Chemical Company Inc based in Elgin, Illinois, United States.

FDA Inspection History

FDA inspections
9
OAI
0
VAI
6
NAI
2
Unclassified
1
Form 483s
1
Warning letters
0

First inspected May 27, 2010. Last inspected July 25, 2025.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Actual vs. theoretical yields not determined1 inspection
  • Cleaning / Sanitizing / Maintenance1 inspection

FDA inspections (9)

DateResultFDA center(s)Insp. #
July 25, 2025Not classifiedHuman Drugs1278401
April 10, 2025NAIFoods & Cosmetics · Colors and Cosmetics Technology1269133
June 24, 2021VAIHuman Drugs · Drug Quality Assurance1147773
January 24, 2020NAIAnimal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices1118998
June 9, 2016VAIFoods & Cosmetics, Human Drugs · Drug Quality Assurance976847
September 4, 2014VAIFoods & Cosmetics, Human Drugs · Drug Quality Assurance885209
July 23, 2013VAIFoods & Cosmetics, Human Drugs · Colors and Cosmetics Technology841988
June 8, 2011VAIFoods & Cosmetics, Human Drugs · Colors and Cosmetics Technology730045
May 27, 2010VAIFoods & Cosmetics, Human Drugs · Drug Quality Assurance663342
FDA documents

Form 483s (1)

  • Form 483s · July 25, 2025

EIRs (1)

  • EIRs · January 24, 2020
People (4)
Vaishali J. Patel
Person
Kenneth D. Abbott
Person
Angela C. Welker
Person
Mary L. Schuckmann
Person
Related Companies (10)

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

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DLC Laboratories, Inc
Pure Source LLC
Pharmaloz Manufacturing Inc.
USANA Health Sciences, Inc.
Bayer HealthCare LLC
Wisconsin Pharmacal Company
Accra-Pac, Inc.
Cosmetics & Cleaners International LLC dba C&C Industries
Company Information

Name

Hydrox Chemical Company Inc

FEI Number

1419821

Address

825 Tollgate Rd, Elgin, Illinois 60123, United States

Country

United States

ID: a598d295-e3b8-4c4d-9d04-2c9f31a7ce78

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