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GOLDEN TIME ENTERPRISES (SHENZHEN) CO. LTD.

⚠️ Moderate Risk

FEI: 2000005615 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

2000005615

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Shang Li Lang, Cha Shan Gong Ye Gu, Bu Ji, Shenzhen, Guangdong, China

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
1
Unique Violations
8/21/2008
Latest Refusal
8/21/2008
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
8/21/2008
66HAS06CYCLAMATE SODIUM (SWEETENER)
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is GOLDEN TIME ENTERPRISES (SHENZHEN) CO. LTD.'s FDA import refusal history?

GOLDEN TIME ENTERPRISES (SHENZHEN) CO. LTD. (FEI: 2000005615) has 1 FDA import refusal record(s) in our database, spanning from 8/21/2008 to 8/21/2008.

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. GOLDEN TIME ENTERPRISES (SHENZHEN) CO. LTD.'s FEI number is 2000005615.

What types of violations has GOLDEN TIME ENTERPRISES (SHENZHEN) CO. LTD. received?

GOLDEN TIME ENTERPRISES (SHENZHEN) CO. LTD. 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 GOLDEN TIME ENTERPRISES (SHENZHEN) CO. LTD. come from?

All FDA import refusal data for GOLDEN TIME ENTERPRISES (SHENZHEN) CO. LTD. 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.