FDA Inspection
Les Importations Herbasante Inc.Les Importations Herbasante Inc. – FDA Inspection, Dec 1, 2017
Record Details
This FDA Inspection record concerns Les Importations Herbasante Inc., with an inspection on December 1, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b6f4d649-77de-47c8-a389-58fdb6f9583f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1033914
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.134(a)Correct labels during finishing operations
- 21 CFR 211.28(b)Habits of good sanitation & health
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.188(b)(12)Documentation of Batch Investigations
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Les Importations Herbasante Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2023 | Not classified | Office of Inspections and Investigations | |
| November 5, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 23, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Les Importations Herbasante Inc.
- FDA Inspection 1215209 - 2023-08-18
- FDA Inspection 948622 - 2015-11-05
- FDA Inspection 849450 - 2013-08-23
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