935880
Jerome Stevens Pharmaceuticals, Inc. — FEI 2431950
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 23, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bohemia, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1449 | 21 CFR 211.111 | Deviations of production time limits |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |