1016800
Linde Eckstein Gmbh + Co KG — FEI 3002683524
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 30, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oberasbach (Germany)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |