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Company
•United States

Chem-Tech, Ltd., Pleasantville, IA – FDA Inspections

Inspection records and compliance data for Chem-Tech, Ltd. in Pleasantville, Iowa. 5 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected September 20, 2024.

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Company Profile

This profile covers Chem-Tech, Ltd. based in Pleasantville, Iowa, United States.

FDA Inspection History

FDA inspections
5
OAI
1
VAI
4
NAI
0
Form 483s
1
Warning letters
1

First inspected September 18, 2009. Last inspected September 20, 2024.

Most cited issue areas

  • Approval and review of procedures2 inspections
  • Scientifically sound laboratory controls2 inspections
  • Absence of Written Procedures1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
September 20, 2024OAIHuman Drugs · Drug Quality Assurance1251164
December 11, 2015VAIHuman Drugs · Drug Quality Assurance965271
October 19, 2011VAIHuman Drugs · Drug Quality Assurance749979
April 15, 2010VAIHuman Drugs · Drug Quality Assurance658316
September 18, 2009VAIAnimal Drugs & Feeds, Human Drugs · Pre-Approval Eval. of Animal Drugs and Food Additives613331
FDA documents

Form 483s (1)

  • Form 483s · September 20, 2024

Warning Letters (1)

  • Warning Letters · September 20, 2024
People (2)
Gretchen L. Trendel
Person
Francis Godwin
Person
Related Companies (10)

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Xinxiang Tuoxin Pharmaceutical Co. Ltd
Pharmasol Corporation
Pfizer, Inc.
Morton Grove Pharmaceuticals, Inc.
Jubilant Cadista Pharmaceuticals, Inc.
The Compounding Shop, Inc.
Company Information

Name

Chem-Tech, Ltd.

FEI Number

1927341

Address

1006 Business Highway 5, Pleasantville, Iowa 50225, United States

Country

United States

ID: 66b8f645-7670-48f0-ab53-c853009ce9c6

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