FDA Inspection 710832 — River's Edge Pharmaceuticals, LLC
The FDA completed an inspection of River's Edge Pharmaceuticals, LLC on April 1, 2011 in Suwanee, GA. 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
- April 1, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Suwanee, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |