697608
MPP PHARMA LLC — FEI 1930436
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 5, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kansas City, MO (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1449 | 21 CFR 211.111 | Deviations of production time limits |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |