1153618
Vitae Enim Vitae Scientific, Inc. — FEI 3014384422
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 22, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |