FDA Inspection
Chemolee Lab CorporationChemolee Lab Corporation – FDA Inspection, Sep 1, 2011
Record Details
This FDA Inspection record concerns Chemolee Lab Corporation, with an inspection on September 1, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Chemolee Lab Corporation
- Inspection Date
- September 1, 2011
- Product Type
- Drugs
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ID · f6e81564-87f6-48c4-b2c1-0accd395224f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 742145
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.110(c)In-process materials characteristics testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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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 |
| July 18, 2013 | VAI | 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 843220 - 2013-07-18
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