FDA Inspection
Laboratoire UnitherLaboratoire Unither – FDA Inspection, Jun 21, 2018
Record Details
This FDA Inspection record concerns Laboratoire Unither, with an inspection on June 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e2155663-e03f-4e87-85b8-8bbe11cd4541
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1057672
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.160(a)Lab controls established, including changes
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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 |
| September 15, 2015 | 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 943780 - 2015-09-15
- FDA Inspection 853044 - 2013-09-19
- FDA Inspection 729962 - 2011-05-16
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