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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.
TerminatedView source data ›
Sep 3, 2021 Class II
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
CompletedView source data ›
Dec 9, 2020 Class II
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
TerminatedView source data ›
Sep 23, 2019 Class II
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
TerminatedView source data ›
Jul 24, 2018 Class II
Defective Container: Tamper Evident foil seal not completely intact.
TerminatedView source data ›
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.
TerminatedView source data ›
Dec 15, 2015 Class III
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
TerminatedView source data ›

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 in FDA source data ›

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)
Mar 19, 2012 · No Action Indicated (NAI)
Nov 6, 2009 · No Action Indicated (NAI)
Form 483 observations
Aug 12, 2025, 7 observations: Microbiological testing; Procedures for non-sterile drug products; Written records kept in individual logs

FDA record timeline

Warning letter
CGMP/Finished Pharmaceuticals/Adulterated
Source ›
FDA inspection
OAI classification
Form 483
7 observations
Recall
Class II — Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Source ›
Recall
Class II — CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Source ›
Recall
Class II — Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Source ›
Recall
Class II — Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Source ›
FDA inspection
NAI classification
Recall
Class II — Defective Container: Tamper Evident foil seal not completely intact.
Source ›
Recall
Class II — Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Source ›
FDA inspection
NAI classification
Recall
Class III — Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Source ›
FDA inspection
NAI classification
FDA inspection
NAI classification

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

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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Accupack MidwestChemco CorporationAerosol and Liquid Packaging, Inc.DENTAL TECHNOLOGIES, INC.Sunstar Americas, Inc.Missouri Analytical Laboratories, Inc.

Source: FDA public data · status as of 2026-08-22

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