FDA Inspection
Chemolee Lab CorporationChemolee Lab Corporation – FDA Inspection, May 18, 2017
Record Details
This FDA Inspection record concerns Chemolee Lab Corporation, with an inspection on May 18, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 98af5f12-e314-483d-ba61-f3800eae0f80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014340
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| 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 |
| 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 916451 - 2015-02-13
- FDA Inspection 843220 - 2013-07-18
- FDA Inspection 742145 - 2011-09-01
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