Sunstar Americas, Inc
FDA inspection history in Schaumburg, Illinois, 2021 to 2023
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2021: one warning letter and one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Two Form 483s and one warning letter, at Schaumburg, Illinois.
- 2021The longest 483 on file: 15 observations over 11 pages at Schaumburg, Illinois.
Cited most
Across all Sunstar Americas observations on file
- 21 CFR 820.100Corrective and preventive action3
- 21 CFR 820.70Production and process controls3
- 21 CFR 820.30Design controls2
- 21 CFR 820.75Process validation2
- 21 CFR 211.113Control of microbiological contamination1
The complete Sunstar Americas file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Schaumburg, Illinois
Two Form 483s and one warning letter · 2021 to 2023 · 16 observations
Latest: Form 483, Feb 10, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-02-10 | 483 Form 483 | Schaumburg, Illinois | 1 | $99 |
| 2021-12-21 | Warning letter Warning letter | Schaumburg, Illinois | — | $99 |
| 2021-02-18 | 483 Form 483 | Schaumburg, Illinois | 15 | $99 |
Investigators on these documents
FEI number 1413787 · most recent document Feb 10, 2023
About Sunstar Americas, Inc
How many FDA Form 483s has Sunstar Americas, Inc received?
FDA Intel has 2 Form 483s on file for Sunstar Americas, Inc; the most recent is dated Feb 10, 2023.
When was Sunstar Americas, Inc last inspected by FDA?
The most recent FDA inspection document on file for Sunstar Americas, Inc is a Form 483 dated Feb 10, 2023, for the site in Schaumburg, Illinois.
What did FDA cite at Sunstar Americas, Inc?
The regulations cited most in the observations on file for Sunstar Americas, Inc are 21 CFR 820.100 (Corrective and preventive action), 3 times; 21 CFR 820.70 (Production and process controls), 3 times; 21 CFR 820.30 (Design controls), 2 times.
Has Sunstar Americas, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sunstar Americas, Inc; the most recent is dated Dec 21, 2021.