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Guang Shui City Clothes Co.

⚠️ Moderate Risk

FEI: 1000555234 • Guang Shui • CHINA

FEI

FEI Number

1000555234

📍

Location

Guang Shui

🇨🇳

Country

CHINA
🏢

Address

Rongqi Da Dao, Rongqi, Shunde, , Guang Shui, , China

Moderate Risk

FDA Import Risk Assessment

35.1
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
9/26/2012
Latest Refusal
8/9/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
4.2×10%
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

2412×

PESTICIDE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:

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).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
9/26/2012
79MWZEXPANDER, BREAST, EXTERNAL
118NOT LISTED
341REGISTERED
Los Angeles District Office (LOS-DO)
8/9/2005
25JGC99ROOT & TUBER VEGETABLE, N.E.C.
241PESTICIDE
Los Angeles District Office (LOS-DO)
8/9/2005
25JGC18LOTUS ROOT (ROOT & TUBER VEGETABLE)
241PESTICIDE
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Guang Shui City Clothes Co.'s FDA import refusal history?

Guang Shui City Clothes Co. (FEI: 1000555234) has 3 FDA import refusal record(s) in our database, spanning from 8/9/2005 to 9/26/2012.

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. Guang Shui City Clothes Co.'s FEI number is 1000555234.

What types of violations has Guang Shui City Clothes Co. received?

Guang Shui City Clothes Co. has been cited for 3 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 Guang Shui City Clothes Co. come from?

All FDA import refusal data for Guang Shui City Clothes Co. 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.