Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2009-03-13.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Mar 2009 | Not recorded | 483 | View 483 → |
| 16 Aug 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Laurie A Haxel1 insp.
Karen E Masley-Joseph1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| 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 site report
Get the verbatim findings behind Haemonetics Software Solutions' 1 Form 483
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat