942184
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 3, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- East Troy, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4376 | 21 CFR 211.188(b)(4) | Weights and measures of components used |
| 4576 | 21 CFR 211.192 | No written record of investigation |