FDA Inspection
Indicus Pharma LLCIndicus Pharma LLC – FDA Inspection, Sep 12, 2012
Record Details
This FDA Inspection record concerns Indicus Pharma LLC, with an inspection on September 12, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Indicus Pharma LLC
- Inspection Date
- September 12, 2012
- Product Type
- Drugs
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ID · c9f1fce0-904c-42ad-abb7-a647f4f555be
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 798430
- 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(b)Failure to review ADE information
- 21 CFR 314.80(b)Failure to develop written procedures
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