Sunstar Americas, Inc.
Form 483 issued February 18, 2021 · Schaumburg, Illinois
- Investigators
- Brian D. Nicholson· Stephen D. Eich
- Observations
- 15
- Pages
- 11
In short: On February 18, 2021, FDA issued a Form 483 with 15 observations to Sunstar Americas, Inc. in Schaumburg, Illinois. The investigators were Brian D. Nicholson and Stephen D. Eich. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75 (1×)
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…
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
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75
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. The most-cited regulation is 21 CFR 820.75 (process validation). 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. Each investigator has a profile showing what they cite most.
When was Sunstar Americas, Inc. inspected by FDA?
This Form 483 is dated February 18, 2021.
How do I get the full Form 483 for Sunstar Americas, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.