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Gold Orient International Limited

⚠️ Moderate Risk

FEI: 3010164259 • Huizhou, Guangdong • CHINA

FEI

FEI Number

3010164259

📍

Location

Huizhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

8th And 9th Fl, No. 2 Building, 1st Phase, No. 3 Shuikou Avenue; Huicheng, Huizhou, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

38.4
LowModerateHighCritical

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

Statistics

7
Total Refusals
4
Unique Violations
6/20/2012
Latest Refusal
12/10/2008
Earliest Refusal

Score Breakdown

Violation Severity
65.8×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
19.8×10%
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

115×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

4715×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

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).

1971×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

Refusal History

DateProductViolationsDivision
6/20/2012
53GY05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
Los Angeles District Office (LOS-DO)
10/19/2011
95RGIHAND WASHING SANITIZER, ULTRAVIOLET HYGIENE PRODUCTS, NON-MEDICAL
118NOT LISTED
Los Angeles District Office (LOS-DO)
12/10/2008
53HD05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS)
11UNSAFE COL
471CSTIC LBLG
Southwest Import District Office (SWI-DO)
12/10/2008
53GC05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
11UNSAFE COL
471CSTIC LBLG
Southwest Import District Office (SWI-DO)
12/10/2008
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
11UNSAFE COL
471CSTIC LBLG
Southwest Import District Office (SWI-DO)
12/10/2008
53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
11UNSAFE COL
471CSTIC LBLG
Southwest Import District Office (SWI-DO)
12/10/2008
53GC05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
11UNSAFE COL
471CSTIC LBLG
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Gold Orient International Limited's FDA import refusal history?

Gold Orient International Limited (FEI: 3010164259) has 7 FDA import refusal record(s) in our database, spanning from 12/10/2008 to 6/20/2012.

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. Gold Orient International Limited's FEI number is 3010164259.

What types of violations has Gold Orient International Limited received?

Gold Orient International Limited has been cited for 4 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 Gold Orient International Limited come from?

All FDA import refusal data for Gold Orient International Limited 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.