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Combe Laboratories, Inc.

⚠️ High Risk

FEI: 1450238 • Rantoul, IL • UNITED STATES

FEI

FEI Number

1450238

📍

Location

Rantoul, IL

🇺🇸
🏢

Address

200 Shellhouse Dr, , Rantoul, IL, United States

High Risk

FDA Import Risk Assessment

53.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

7
Total Refusals
1
Unique Violations
6/10/2011
Latest Refusal
6/10/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

757×

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
6/10/2011
60QAL69PRAMOXINE HCL (ANESTHETIC)
75UNAPPROVED
New York District Office (NYK-DO)
6/10/2011
60QBL56BENZOCAINE (ANESTHETIC)
75UNAPPROVED
New York District Office (NYK-DO)
6/10/2011
60QBL56BENZOCAINE (ANESTHETIC)
75UNAPPROVED
New York District Office (NYK-DO)
6/10/2011
60QBR56BENZOCAINE (ANESTHETIC)
75UNAPPROVED
New York District Office (NYK-DO)
6/10/2011
60QBL56BENZOCAINE (ANESTHETIC)
75UNAPPROVED
New York District Office (NYK-DO)
6/10/2011
60QBL56BENZOCAINE (ANESTHETIC)
75UNAPPROVED
New York District Office (NYK-DO)
6/10/2011
60QBL56BENZOCAINE (ANESTHETIC)
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Combe Laboratories, Inc.'s FDA import refusal history?

Combe Laboratories, Inc. (FEI: 1450238) has 7 FDA import refusal record(s) in our database, spanning from 6/10/2011 to 6/10/2011.

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. Combe Laboratories, Inc.'s FEI number is 1450238.

What types of violations has Combe Laboratories, Inc. received?

Combe Laboratories, Inc. has been cited for 1 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 Combe Laboratories, Inc. come from?

All FDA import refusal data for Combe Laboratories, 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.