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Cosette Pharmaceuticals NC Laboratories, LLC

⚠️ Moderate Risk

FEI: 1053439 • Lincolnton, NC • UNITED STATES

FEI

FEI Number

1053439

📍

Location

Lincolnton, NC

🇺🇸
🏢

Address

1877 Kawai Rd, , Lincolnton, NC, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/6/2012
Latest Refusal
4/6/2012
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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).

751×

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
4/6/2012
61WBJ18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Cosette Pharmaceuticals NC Laboratories, LLC's FDA import refusal history?

Cosette Pharmaceuticals NC Laboratories, LLC (FEI: 1053439) has 1 FDA import refusal record(s) in our database, spanning from 4/6/2012 to 4/6/2012.

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. Cosette Pharmaceuticals NC Laboratories, LLC's FEI number is 1053439.

What types of violations has Cosette Pharmaceuticals NC Laboratories, LLC received?

Cosette Pharmaceuticals NC Laboratories, LLC 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 Cosette Pharmaceuticals NC Laboratories, LLC come from?

All FDA import refusal data for Cosette Pharmaceuticals NC Laboratories, LLC 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.