FDA Inspection
Moko Therapeutics, LLCMoko Therapeutics, LLC – FDA Inspection, Jan 23, 2012
Record Details
This FDA Inspection record concerns Moko Therapeutics, LLC, with an inspection on January 23, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Moko Therapeutics, LLC
- Inspection Date
- January 23, 2012
- Product Type
- Drugs
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ID · a1641f98-5907-4e2f-997b-a371c197187d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 764721
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 310.305(c)Failure to submit ADE report
- 21 CFR 211.142Written warehousing procedures established/followed
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Other FDA inspections of Moko Therapeutics, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2011 | OAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
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