FDA Inspection
BoironBoiron – FDA Inspection, Jan 30, 2015
Record Details
This FDA Inspection record concerns Boiron, with an inspection on January 30, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Boiron
- Inspection Date
- January 30, 2015
- Product Type
- Drugs
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ID · af97f3ec-2af2-4b41-bab8-e09b4cf9f363
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 912269
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.56(b)Written sanitation procedures lacking
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Other FDA inspections of Boiron
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 29, 2024 | Not classified | Office of Inspections and Investigations | |
| June 19, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Boiron
- FDA Inspection 1255607 - 2024-11-29
- FDA Inspection 1065418 - 2018-06-19
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