Overview
- 12 public-safe observations are available for this inspection.
- 12 structured CFR citations are represented.
- 4 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
23 May 2014
21 CFR 211.25(a)
Training--operations, GMPs, written procedures
Cited by Sharon K Thoma, Lloyd D Payne, Sina Shojaee, Rose M Ashley
23 May 2014
21 CFR 211.84(b)
Representative Samples
Cited by Sharon K Thoma, Lloyd D Payne, Sina Shojaee, Rose M Ashley
23 May 2014
21 CFR 211.84(d)(2)
Reports of Analysis (Components)
Cited by Sharon K Thoma, Lloyd D Payne, Sina Shojaee, Rose M Ashley
23 May 2014
21 CFR 211.84(d)(3)
Container/Closure Written Test Procedure
Cited by Sharon K Thoma, Lloyd D Payne, Sina Shojaee, Rose M Ashley
23 May 2014
21 CFR 211.101(d)
Verification of component addition
Cited by Sharon K Thoma, Lloyd D Payne, Sina Shojaee, Rose M Ashley
Inspected site
OIOtsuka ICU Medical LLCAustin, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.101(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.184(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
Source document
PDF
PDF available
Form 483 source document
The source document is available to authorized Atlas users.
Full 483 report
Get the verbatim text of all 12 observations
The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere