FDA Inspection
Laboratoires BoironLaboratoires Boiron – FDA Inspection, Jan 20, 2015
Record Details
This FDA Inspection record concerns Laboratoires Boiron, with an inspection on January 20, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Laboratoires Boiron
- Inspection Date
- January 20, 2015
- Product Type
- Drugs
View Company Profile
ID · 3a47329b-06ac-43b2-86cd-6b2cface88e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 912249
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.192Written record of investigation incomplete
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