FDA Inspection
Chemolee Lab CorporationChemolee Lab Corporation – FDA Inspection, Feb 13, 2015
Record Details
This FDA Inspection record concerns Chemolee Lab Corporation, with an inspection on February 13, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Chemolee Lab Corporation
- Inspection Date
- February 13, 2015
- Product Type
- Drugs
View Company Profile
ID · d53d854a-1af5-47f6-9bdd-3f401451b274
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 916451
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.84(b)Representative Samples
Showing 10 of 13 citations.
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 |
| July 18, 2013 | VAI | 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 843220 - 2013-07-18
- 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.