685826
Welch, Holme & Clark Co., Inc — FEI 2211876
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 29, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Newark, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1636 | 21 CFR 211.130(e) | Packaging line inspection before use |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3630 | 21 CFR 211.170(b) | Drug product reserve containers |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4380 | 21 CFR 211.198(b)(3) | Determination not to conduct investigation of complaint |