FDA Inspection
Biomeasure, Incorporated/Ipsen GroupBiomeasure, Incorporated/Ipsen Group – FDA Inspection, Jul 17, 2009
Record Details
This FDA Inspection record concerns Biomeasure, Incorporated/Ipsen Group, with an inspection on July 17, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 17, 2009
- Product Type
- Drugs
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ID · 299a5c64-edc0-498b-920e-a89805880eca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 603370
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 314.80(c)Failure by applicant to report ADE
- 21 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
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