FDA Inspection
BoironBoiron – FDA Inspection, Jul 7, 2017
Record Details
This FDA Inspection record concerns Boiron, with an inspection on July 7, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · cc619ba0-ee60-4ad7-89ae-a08f3939e4a2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017861
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
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Other FDA inspections of Boiron
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 15, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Boiron
- FDA Inspection 1277384 - 2023-09-15
- FDA Inspection 1123836 - 2018-09-28
- FDA Inspection 912250 - 2015-01-15
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