Overview
- 9 public-safe observations are available for this inspection.
- 8 structured CFR citations are represented.
- 3 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
2 Mar 2009
21 CFR 211.22(c)
Approve or reject procedures or specs
Cited by Robert D Tollefsen, Nancy E Byerly, Nancy A Saxenian Emmons
2 Mar 2009
21 CFR 211.68(a)
Written calibration / inspection records not kept
Cited by Robert D Tollefsen, Nancy E Byerly, Nancy A Saxenian Emmons
2 Mar 2009
21 CFR 211.100(a)
Approval and review of procedures
Cited by Robert D Tollefsen, Nancy E Byerly, Nancy A Saxenian Emmons
2 Mar 2009
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Robert D Tollefsen, Nancy E Byerly, Nancy A Saxenian Emmons
2 Mar 2009
21 CFR 211.160(b)(4)
Test devices not meeting specifications
Cited by Robert D Tollefsen, Nancy E Byerly, Nancy A Saxenian Emmons
Inspected site
AUAirgas USA LLCKent, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | 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 211.160(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.180(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.186(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 9 observations
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