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Blistex Inc

⚠️ Moderate Risk

FEI: 1413077 • Oak Brook, IL • UNITED STATES

FEI

FEI Number

1413077

📍

Location

Oak Brook, IL

🇺🇸
🏢

Address

1800 Swift Dr, , Oak Brook, IL, United States

Moderate Risk

FDA Import Risk Assessment

37.1
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

5
Total Refusals
2
Unique Violations
8/7/2014
Latest Refusal
2/13/2012
Earliest Refusal

Score Breakdown

Violation Severity
66.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
20.1×10%
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

1183×

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).

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
8/7/2014
65LBJ99PROTECTANT N.E.C.
118NOT LISTED
Southwest Import District Office (SWI-DO)
2/13/2012
53LK06MOISTURIZING (SKIN CARE PREPARATIONS)
118NOT LISTED
Florida District Office (FLA-DO)
2/13/2012
53LK06MOISTURIZING (SKIN CARE PREPARATIONS)
118NOT LISTED
Florida District Office (FLA-DO)
2/13/2012
60QBJ56BENZOCAINE (ANESTHETIC)
75UNAPPROVED
Florida District Office (FLA-DO)
2/13/2012
60QBL56BENZOCAINE (ANESTHETIC)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Blistex Inc's FDA import refusal history?

Blistex Inc (FEI: 1413077) has 5 FDA import refusal record(s) in our database, spanning from 2/13/2012 to 8/7/2014.

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. Blistex Inc's FEI number is 1413077.

What types of violations has Blistex Inc received?

Blistex Inc 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 Blistex Inc come from?

All FDA import refusal data for Blistex Inc 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.