FDA Inspection
Les Importations Herbasante Inc.Les Importations Herbasante Inc. – FDA Inspection, Aug 23, 2013
Record Details
This FDA Inspection record concerns Les Importations Herbasante Inc., with an inspection on August 23, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 23, 2013
- Product Type
- Drugs
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ID · 87cf5801-56db-4cb4-bc23-652b003e49c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 849450
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
- 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 | |
| December 1, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 5, 2015 | 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 1033914 - 2017-12-01
- FDA Inspection 948622 - 2015-11-05
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