Company
United StatesChem-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.
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)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 20, 2024 | OAI | Human Drugs · Drug Quality Assurance | 1251164 |
| December 11, 2015 | VAI | Human Drugs · Drug Quality Assurance | 965271 |
| October 19, 2011 | VAI | Human Drugs · Drug Quality Assurance | 749979 |
| April 15, 2010 | VAI | Human Drugs · Drug Quality Assurance | 658316 |
| September 18, 2009 | VAI | Animal Drugs & Feeds, Human Drugs · Pre-Approval Eval. of Animal Drugs and Food Additives | 613331 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
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