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PARTY TYME WORLD

⚠️ Moderate Risk

FEI: 3021251112 • Noyers-Sur-Cher, Loir-et-Cher • FRANCE

FEI

FEI Number

3021251112

📍

Location

Noyers-Sur-Cher, Loir-et-Cher

🇫🇷

Country

FRANCE
🏢

Address

Zone Artisanale Les Plantes, 5 Rue Johannes Gutenberg, Noyers-Sur-Cher, Loir-et-Cher, France

Moderate Risk

FDA Import Risk Assessment

35.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/15/2022
Latest Refusal
8/15/2022
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
17.8×20%
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

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
8/15/2022
86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PARTY TYME WORLD's FDA import refusal history?

PARTY TYME WORLD (FEI: 3021251112) has 1 FDA import refusal record(s) in our database, spanning from 8/15/2022 to 8/15/2022.

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. PARTY TYME WORLD's FEI number is 3021251112.

What types of violations has PARTY TYME WORLD received?

PARTY TYME WORLD 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 PARTY TYME WORLD come from?

All FDA import refusal data for PARTY TYME WORLD 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.