FDA Inspection
Moko Therapeutics, LLCMoko Therapeutics, LLC – FDA Inspection, Apr 28, 2011
Record Details
This FDA Inspection record concerns Moko Therapeutics, LLC, with an inspection on April 28, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Moko Therapeutics, LLC
- Inspection Date
- April 28, 2011
- Product Type
- Drugs
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ID · 33196446-a0cb-4671-988c-35a8eff282b2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 721912
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
FDA Citations
2- 21 CFR 310.305(c)Failure to submit ADE report
- 21 CFR 310.305(a)Failure to develop written procedures
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Other FDA inspections of Moko Therapeutics, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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