Company
United StatesChemolee Lab Corporation, Irving, TX – FDA Inspections
Inspection records and compliance data for Chemolee Lab Corporation in Irving, Texas. 7 FDA inspections on record (2 OAI), 2 Form 483s, last inspected May 30, 2025.
Company Profile
This profile covers Chemolee Lab Corporation based in Irving, Texas, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 2
- VAI
- 4
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected December 21, 2009. Last inspected May 30, 2025.
Most cited issue areas
- Scientifically sound laboratory controls5 inspections
- Computer control of master formula records3 inspections
- Prepared for each batch, include complete information3 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 30, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1271501 |
| February 10, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1119703 |
| May 18, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1014340 |
| February 13, 2015 | OAI | Human Drugs · Drug Quality Assurance | 916451 |
| July 18, 2013 | VAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 843220 |
| September 1, 2011 | OAI | Human Drugs · Drug Quality Assurance | 742145 |
| December 21, 2009 | VAI | Human Drugs · Drug Quality Assurance | 636070 |
FDA documents
Form 483s (1)
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Company Information
Name
Chemolee Lab Corporation
FEI Number
1642813
Address
3820 Conflans Rd, Irving, Texas 75061, United States
Country
United States
ID: e3c269ed-41e0-47d1-a09f-074a499f6846