Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-06-16.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jun 2022 – 16 Jun 2022 | Biologics | Clean | |
| 23 Sep 2019 – 26 Sep 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Sep 2019 – 19 Sep 2019 | Biologics | Clean | |
| 8 Jul 2014 | Medical Devices & Rad Health | Clean | |
| 17 Mar 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Sep 2019
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Eric C Fox
26 Sep 2019
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Eric C Fox
26 Sep 2019
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Eric C Fox
Investigators
FDA investigators tied to this site in the record.
Ka L Wong1 insp.
Creighton T Tuzon1 insp.
Eric C Fox1 insp.
William F Lagud1 insp.
Janete A Oliveira1 insp.
Janete A Eaker1 insp.
Bonnie E Pierson1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Mediware Information Systems Inc - HQ's 1 Form 483
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