FDA Inspection 721912 — Moko Therapeutics, LLC
The FDA completed an inspection of Moko Therapeutics, LLC on April 28, 2011 in Encinitas, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 28, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Postmarket Surv. and Epidemiology
- Location
- Encinitas, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 10022 | 21 CFR 310.305(a) | Failure to develop written procedures |
| 6705 | 21 CFR 310.305(c) | Failure to submit ADE report |