ImportRefusal LogoImportRefusal

Coty USA LLC dba Del Pharmaceuticals, Inc.

⚠️ Moderate Risk

FEI: 3001238190 • Rocky Point, NC • UNITED STATES

FEI

FEI Number

3001238190

📍

Location

Rocky Point, NC

🇺🇸
🏢

Address

1830 Carver Dr, , Rocky Point, NC, United States

Moderate Risk

FDA Import Risk Assessment

31.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
7/29/2010
Latest Refusal
7/29/2010
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

4736×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4754×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

Refusal History

DateProductViolationsDivision
7/29/2010
53GI05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
7/29/2010
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
7/29/2010
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
7/29/2010
53HD05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS)
473LABELING
475COSMETLBLG
New York District Office (NYK-DO)
7/29/2010
53HD05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS)
473LABELING
New York District Office (NYK-DO)
7/29/2010
53HD05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS)
473LABELING
New York District Office (NYK-DO)

Frequently Asked Questions

What is Coty USA LLC dba Del Pharmaceuticals, Inc.'s FDA import refusal history?

Coty USA LLC dba Del Pharmaceuticals, Inc. (FEI: 3001238190) has 6 FDA import refusal record(s) in our database, spanning from 7/29/2010 to 7/29/2010.

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. Coty USA LLC dba Del Pharmaceuticals, Inc.'s FEI number is 3001238190.

What types of violations has Coty USA LLC dba Del Pharmaceuticals, Inc. received?

Coty USA LLC dba Del Pharmaceuticals, 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 Coty USA LLC dba Del Pharmaceuticals, Inc. come from?

All FDA import refusal data for Coty USA LLC dba Del Pharmaceuticals, 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.