752344
Pharmalogic South Carolina LLC — FEI 3005391759
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 3, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Duncan, SC (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1725 | 21 CFR 211.134(c) | Examinations documented |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4316 | 21 CFR 211.84(d)(3) | Testing Containers & Closures Conformity with Specs |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |