FDA Inspection 1034621 — Manna Omni International, Inc.
The FDA completed an inspection of Manna Omni International, Inc. on December 8, 2017 in Fullerton, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 8, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Fullerton, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |