Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
13 Mar 2009
21 CFR 820.22
Quality Audit/Reaudit - conducted
Cited by Laurie A Haxel, Karen E Masley-Joseph
13 Mar 2009
21 CFR 820.40(b)
Document change records, maintained.
Cited by Laurie A Haxel, Karen E Masley-Joseph
13 Mar 2009
21 CFR 820.100(a)(1)
Procedure for analysis of data sources
Cited by Laurie A Haxel, Karen E Masley-Joseph
13 Mar 2009
21 CFR 820.100(a)(2)
Investigation procedures
Cited by Laurie A Haxel, Karen E Masley-Joseph
Inspected site
HSHaemonetics Software SolutionsRosemont, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(b) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 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