FDA Inspection 764721 — Moko Therapeutics, LLC
The FDA completed an inspection of Moko Therapeutics, LLC on January 23, 2012 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
- January 23, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Encinitas, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 6705 | 21 CFR 310.305(c) | Failure to submit ADE report |