FDA Inspection 606069 — River's Edge Pharmaceuticals, LLC
The FDA completed an inspection of River's Edge Pharmaceuticals, LLC on August 12, 2009 in Suwanee, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 16 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 12, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Suwanee, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 2621 | 21 CFR 211.198(b)(3) | Reason for Not Conducting Complaint Investigation |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |