FDA Inspection
Blansett Pharmacal Co, IncBlansett Pharmacal Co, Inc – FDA Inspection, Sep 22, 2009
Record Details
This FDA Inspection record concerns Blansett Pharmacal Co, Inc, with an inspection on September 22, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Blansett Pharmacal Co, Inc
- Inspection Date
- September 22, 2009
- Product Type
- Drugs
View Company Profile
ID · 5e869c93-ba3a-4f0c-8093-56d3bc23c5b3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 615247
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 310.305(c)Failure to submit ADE report
- 21 CFR 310.305(c)(2)Investigation of serious, unexpected events
- 21 CFR 310.305(a)Failure to develop written procedures
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