Drug establishmentActive, Registered FY2026Official Action Indicated

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.

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

OngoingView source data ›

Oct 27, 2020 Class I

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

CompletedView source data ›

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 in FDA source data ›

Inspection history

Inspections on file

Feb 10, 2023 · Voluntary Action Indicated (VAI)
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 3, 2013 · No Action Indicated (NAI)
Dec 20, 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

FDA record timeline

Feb 10, 2023

FDA inspection

VAI classification

Feb 10, 2023

Form 483

1 observation

Feb 18, 2021

FDA inspection

OAI classification

Feb 18, 2021

FDA inspection

NAI classification

Dec 28, 2020

Recall

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

Source ›

Oct 27, 2020

Recall

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

Source ›

Jun 6, 2016

FDA inspection

NAI classification

Dec 16, 2014

FDA inspection

NAI classification

Dec 3, 2013

FDA inspection

NAI classification

Dec 20, 2011

FDA inspection

NAI classification

Oct 27, 2011

FDA inspection

NAI classification

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

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?

FDA has not posted a warning letter for Sunstar Americas, Inc.. FDA publishes only a subset of enforcement records, so this is not a guarantee.

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 2026-08-22