FDA Inspection
Aton Pharma Inc.Aton Pharma Inc. – FDA Inspection, Sep 10, 2009
Record Details
This FDA Inspection record concerns Aton Pharma Inc., with an inspection on September 10, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aton Pharma Inc.
- Inspection Date
- September 10, 2009
- Product Type
- Drugs
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ID · 3ed257e0-6494-4a38-aa66-f8b6fa3d6f7a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 610032
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 314.80(c)Failure by applicant to report ADE
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
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