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Fareva Morton Grove

✅ Low Risk

FEI: 1410794 • Morton Grove, IL • UNITED STATES

FEI

FEI Number

1410794

📍

Location

Morton Grove, IL

🇺🇸
🏢

Address

6901 Golf Rd, , Morton Grove, IL, United States

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
12/22/2015
Latest Refusal
12/22/2015
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

30001×

N-RX INACT

The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.

Refusal History

DateProductViolationsDivision
12/22/2015
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
3000N-RX INACT
New York District Office (NYK-DO)

Frequently Asked Questions

What is Fareva Morton Grove's FDA import refusal history?

Fareva Morton Grove (FEI: 1410794) has 1 FDA import refusal record(s) in our database, spanning from 12/22/2015 to 12/22/2015.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Fareva Morton Grove's FEI number is 1410794.

What types of violations has Fareva Morton Grove received?

Fareva Morton Grove has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Fareva Morton Grove come from?

All FDA import refusal data for Fareva Morton Grove is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.