FDA Inspection
Chemolee Lab CorporationChemolee Lab Corporation – FDA Inspection, Jul 18, 2013
Record Details
This FDA Inspection record concerns Chemolee Lab Corporation, with an inspection on July 18, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Chemolee Lab Corporation
- Inspection Date
- July 18, 2013
- Product Type
- Drugs
View Company Profile
ID · d8ef0f4b-931f-449b-8a9b-dc47e9469170
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 843220
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.22(a)Approve or reject components, products
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Chemolee Lab Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 30, 2025 | VAI | Dallas District Office | Drug Quality Assurance |
| February 10, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 18, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 13, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 1, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Chemolee Lab Corporation
- FDA Inspection 1271501 - 2025-05-30
- FDA Inspection 1119703 - 2020-02-10
- FDA Inspection 1014340 - 2017-05-18
- FDA Inspection 916451 - 2015-02-13
- FDA Inspection 742145 - 2011-09-01
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.