Overview
- 16 public-safe observations are available for this inspection.
- 15 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.
24 Aug 2012
21 CFR 211.25(a)
Training , Education , Experience overall
Cited by Margaret M Annes, Lucas B Leake, Sharon K Thoma, Sina Shojaee
24 Aug 2012
21 CFR 211.52
Washing and toilet facilities not provided and accessible
Cited by Margaret M Annes, Lucas B Leake, Sharon K Thoma, Sina Shojaee
24 Aug 2012
21 CFR 211.58
Buildings not maintained in good state of repair
Cited by Margaret M Annes, Lucas B Leake, Sharon K Thoma, Sina Shojaee
24 Aug 2012
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Margaret M Annes, Lucas B Leake, Sharon K Thoma, Sina Shojaee
24 Aug 2012
21 CFR 211.80(d)
Identification of Each Lot in Each Shipment
Cited by Margaret M Annes, Lucas B Leake, Sharon K Thoma, Sina Shojaee
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 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(a) | 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) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.58 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.80(d) | 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)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | 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 16 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