Sunstar Americas, Inc
Form 483 issued February 10, 2023 · Schaumburg, Illinois
- Inspection
- Jan 26 – Feb 10, 2023
- Investigator
- Amanda Dinaro
- Observations
- 1
- Pages
- 4
- FEI number
- 1413787
In short: On February 10, 2023, FDA issued a Form 483 with 1 observation to Sunstar Americas, Inc in Schaumburg, Illinois (FEI 1413787) after an inspection that ran Jan 26 – Feb 10, 2023. The investigator was Amanda Dinaro. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×) · 820.100 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
This inspection in context
Amanda Dinaro
7 documents · 2017–2023
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Illinois.
The firmSunstar Americas, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sunstar Americas, Inc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Sunstar Americas, Inc?
Amanda Dinaro is named on this Form 483, for the inspection of Jan 26 – Feb 10, 2023. Each investigator has a profile showing what they cite most.
When was Sunstar Americas, Inc inspected by FDA?
The inspection ran Jan 26 – Feb 10, 2023, and the Form 483 is dated February 10, 2023.
How do I get the full Form 483 for Sunstar Americas, Inc?
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