FDA Inspection 977279 — Medical Foods LLC
The FDA completed an inspection of Medical Foods LLC on July 1, 2016 in Southgate, 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
- July 1, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Southgate, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7459 | 21 CFR 312.57(a) | Records of receipt, shipment, disposition |
| 7461 | 21 CFR 312.58(a) | FDA access to sponsor records |
| 7479 | 21 CFR 312.56(a) | Monitoring investigations |
| 7639 | 21 CFR 312.20(b) | Starting a study before IND is in effect |