FDA Inspection
Laboratoire UnitherLaboratoire Unither – FDA Inspection, Sep 15, 2015
Record Details
This FDA Inspection record concerns Laboratoire Unither, with an inspection on September 15, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Laboratoire Unither
- Inspection Date
- September 15, 2015
- Product Type
- Drugs
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ID · b3e8c454-851a-4f30-a1c3-bbfc321fc1b3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 943780
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
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Other FDA inspections of Laboratoire Unither
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 22, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 16, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laboratoire Unither
- FDA Inspection 1198468 - 2021-10-22
- FDA Inspection 1057672 - 2018-06-21
- FDA Inspection 853044 - 2013-09-19
- FDA Inspection 729962 - 2011-05-16
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