FDA Inspection
BoironBoiron – FDA Inspection, Jan 15, 2015
Record Details
This FDA Inspection record concerns Boiron, with an inspection on January 15, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Boiron
- Inspection Date
- January 15, 2015
- Product Type
- Drugs
View Company Profile
ID · 01522329-0af4-4938-b4a1-81349a971451
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 912250
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.192Written record of investigation incomplete
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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 |
| July 7, 2017 | 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 1017861 - 2017-07-07
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