796073
Otsuka ICU Medical LLC — FEI 1628454
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 24, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1796 | 21 CFR 211.80(d) | Identification of Each Lot in Each Shipment |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1845 | 21 CFR 211.84(d)(3) | Container/Closure Written Test Procedure |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3558 | 21 CFR 211.52 | Washing and toilet facilities not provided and accessible |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 8907 | 21 CFR 314.81(b)(1)(ii) | Contamination, chemical or physical change, deterioration |