FDA Inspection
Boiron Inc.Boiron Inc. – FDA Inspection, Oct 25, 2021
Record Details
This FDA Inspection record concerns Boiron Inc., with an inspection on October 25, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Boiron Inc.
- Inspection Date
- October 25, 2021
- Product Type
- Drugs
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ID · 2188dede-62b5-4eb4-9df0-73f9607ca7a0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1155509
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Boiron Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2026 | Not classified | Philadelphia District Office | Drug Quality Assurance |
| February 14, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 18, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Boiron Inc.
- FDA Inspection 1324326 - 2026-06-26
- FDA Inspection 1007059 - 2017-02-14
- FDA Inspection 716890 - 2011-03-18
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