Drug establishmentActive, Registered FY2026FDA warning letter on file

Fareva Morton Grove, Inc.

Fareva Morton Grove, Inc. is an FDA-registered drug establishment (FEI 1410794) located in Morton Grove, Illinois. The facility is active, registered for FY2026. Its most recent FDA inspection on record (2025-08-12) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Mar 3, 2026

CGMP/Finished Pharmaceuticals/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 (7)

Feb 21, 2022 Class II

Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.

Terminated

Sep 3, 2021 Class II

CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.

Completed

Dec 9, 2020 Class II

Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.

Terminated

Sep 23, 2019 Class II

Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14

Terminated

Jul 24, 2018 Class II

Defective Container: Tamper Evident foil seal not completely intact.

Terminated

Aug 10, 2017 Class II

Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.

Terminated

Dec 15, 2015 Class III

Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.

Terminated

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

Establishment record

FEI Number

1410794

Address

6901 Golf Rd, Morton Grove, Illinois

Establishment type

Drug establishment

Products / operations

Analytical testing, Labeling, Manufacturing, Packaging

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Aug 12, 2025 · Official Action Indicated (OAI)
Sep 18, 2019 · No Action Indicated (NAI)
Feb 2, 2016 · No Action Indicated (NAI)
Feb 2, 2016 · No Action Indicated (NAI)
Feb 2, 2016 · No Action Indicated (NAI)
Mar 19, 2012 · No Action Indicated (NAI)
Mar 19, 2012 · No Action Indicated (NAI)
Mar 19, 2012 · No Action Indicated (NAI)
Nov 6, 2009 · No Action Indicated (NAI)
Nov 6, 2009 · No Action Indicated (NAI)

Form 483 observations

Aug 12, 2025, 7 observations: Valid stability test methods; Written records kept in individual logs; Procedures for non-sterile drug products

Questions

Is Fareva Morton Grove, Inc. registered with the FDA?

Yes. Fareva Morton Grove, Inc. is an FDA-registered drug establishment (FEI 1410794) in Morton Grove, Illinois. Its current registration status is Active, Registered FY2026.

Has Fareva Morton Grove, Inc. received an FDA warning letter?

Yes. FDA issued a warning letter to Fareva Morton Grove, Inc.; the most recent is dated Mar 3, 2026 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Fareva Morton Grove, Inc. do?

Fareva Morton Grove, Inc.'s FDA-registered operations are: Analytical testing, Labeling, Manufacturing, Packaging.

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