1009107
Ridge Properties, LLC — FEI 3011007272
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 16, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Salem, OR (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1794 | 21 CFR 211.80(d) | Disposition recorded by lot identification |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |