FDA Inspection 880543 — Otsuka ICU Medical LLC
The FDA completed an inspection of Otsuka ICU Medical LLC on May 23, 2014 in Austin, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 23, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Austin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1845 | 21 CFR 211.84(d)(3) | Container/Closure Written Test Procedure |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3581 | 21 CFR 211.101(d) | Verification of component addition |
| 3614 | 21 CFR 211.160(b)(4) | Written calibration procedures |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |