FDA Inspection
Alchem International Ltd.Alchem International Ltd. – FDA Inspection, Sep 6, 2019
Record Details
This FDA Inspection record concerns Alchem International Ltd., with an inspection on September 6, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6142f71f-c903-44bd-9bc6-37ecdbf5fc73
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101273
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Alchem International Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 4, 2025 | Not classified | Office of Inspections and Investigations | |
| September 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 1, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 11, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 8, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Alchem International Ltd.
- FDA Inspection 1279310 - 2025-07-04
- FDA Inspection 1028256 - 2017-09-15
- FDA Inspection 964030 - 2016-04-01
- FDA Inspection 790556 - 2012-07-11
- FDA Inspection 629985 - 2009-10-08
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