FDA Inspection
Shalem Products IncShalem Products Inc – FDA Inspection, Sep 24, 2019
Record Details
This FDA Inspection record concerns Shalem Products Inc, with an inspection on September 24, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d9cfb9cb-2d0f-4727-ac11-0dd7bd2f4c30
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1103066
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.160(b)Scientifically sound laboratory controls
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Shalem Products Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 24, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 21, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 18, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Shalem Products Inc
- FDA Inspection 888478 - 2014-06-30
- FDA Inspection 847508 - 2013-07-24
- FDA Inspection 652445 - 2010-02-21
- FDA Inspection 610952 - 2009-08-18
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