765308
Nomax, Inc. — FEI 1937310
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 31, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3630 | 21 CFR 211.170(b) | Drug product reserve containers |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |