Drug establishmentActive, Registered FY2026FDA warning letter on file

Sunstar Americas, Inc.

Sunstar Americas, Inc. is an FDA-registered drug establishment (FEI 1413787) located in Schaumburg, Illinois. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2023-02-10) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Dec 21, 2021

CGMP/QSR/Medical Devices/Adulterated

Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Recalls (2)

Dec 28, 2020 Class II

cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary c

Ongoing

Oct 27, 2020 Class I

Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.

Completed

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number

1413787

Address

301 E. Central Road, Schaumburg, Illinois

Establishment type

Drug establishment

Products / operations

Labeling, Packaging, Relabeling, Repackaging

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Feb 10, 2023 · Voluntary Action Indicated (VAI)
Feb 10, 2023 · Voluntary Action Indicated (VAI)
Feb 18, 2021 · Official Action Indicated (OAI)
Feb 18, 2021 · Official Action Indicated (OAI)
Feb 18, 2021 · No Action Indicated (NAI)
Jun 6, 2016 · No Action Indicated (NAI)
Dec 16, 2014 · No Action Indicated (NAI)
Dec 16, 2014 · No Action Indicated (NAI)
Dec 3, 2013 · No Action Indicated (NAI)
Dec 20, 2011 · No Action Indicated (NAI)
Oct 27, 2011 · No Action Indicated (NAI)
Oct 27, 2011 · No Action Indicated (NAI)

Form 483 observations

Feb 10, 2023, 1 observation: Lack of or inadequate procedures

Questions

Is Sunstar Americas, Inc. registered with the FDA?

Yes. Sunstar Americas, Inc. is an FDA-registered drug establishment (FEI 1413787) in Schaumburg, Illinois. Its current registration status is Active, Registered FY2026.

Has Sunstar Americas, Inc. received an FDA warning letter?

Yes. FDA issued a warning letter to Sunstar Americas, Inc.; the most recent is dated Dec 21, 2021 (CGMP/QSR/Medical Devices/Adulterated).

What does Sunstar Americas, Inc. do?

Sunstar Americas, Inc.'s FDA-registered operations are: Labeling, Packaging, Relabeling, Repackaging.

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Source: FDA public data · status as of 2026-06-06