Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-02-10.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 26 Jan 2023 – 10 Feb 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Jan 2021 – 18 Feb 2021 | Human Drugs | WL | On file |
| 6 Jun 2016 | Biologics | Clean | |
| 9 Dec 2014 – 16 Dec 2014 | Medical Devices & Rad Health | Clean | |
| 3 Dec 2013 | Biologics | Clean | |
| 20 Dec 2011 | Not recorded | Clean | |
| 27 Oct 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Amanda Dinaro1 insp.
Stephen D Eich1 insp.
Brian D Nicholson1 insp.
Leeterry Moore1 insp.
John M Seale1 insp.
Lauren A Crivellone1 insp.
Christina A Miller1 insp.
Patricia A Mcilroy1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sunstar Americas, Inc.'s 2 Form 483s
Source PDFs 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