Sunstar Americas, Inc
Form 483 issued February 18, 2021 · Schaumburg, Illinois
- Inspection
- Jan 12 – Feb 18, 2021
- Investigators
- Brian D. Nicholson· Stephen D. Eich
- Observations
- 15
- Pages
- 11
- FEI number
- 1413787
In short: On February 18, 2021, FDA issued a Form 483 with 15 observations to Sunstar Americas, Inc in Schaumburg, Illinois (FEI 1413787) after an inspection that ran Jan 12 – Feb 18, 2021. The investigators were Brian D. Nicholson and Stephen D. Eich. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Observations span 4 systems, led by production & process controls.
Most cited: 21 CFR 820.70 (3×) · 820.75 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
A validated process was not reviewed and evaluated or revalidated when changes…
- 03
Production processes were not adequately monitored to ensure that a device…
- 04
Procedures to Control environmental conditions have…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) 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 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sunstar Americas, Inc?
FDA listed 15 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Sunstar Americas, Inc?
Brian D. Nicholson and Stephen D. Eich are named on this Form 483, for the inspection of Jan 12 – Feb 18, 2021. Each investigator has a profile showing what they cite most.
When was Sunstar Americas, Inc inspected by FDA?
The inspection ran Jan 12 – Feb 18, 2021, and the Form 483 is dated February 18, 2021.
How do I get the full Form 483 for Sunstar Americas, Inc?
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