723658
Otsuka ICU Medical LLC — FEI 1628454
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 27, 2011
- Fiscal Year
- 2011
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |