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Guangzhou Baiyun District Yalu

⚠️ Moderate Risk

FEI: 3005291432 • Guangzhou • CHINA

FEI

FEI Number

3005291432

📍

Location

Guangzhou

🇨🇳

Country

CHINA
🏢

Address

445 Tianhe N Rd, , Guangzhou, , China

Moderate Risk

FDA Import Risk Assessment

42.1
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
2/20/2008
Latest Refusal
1/26/2007
Earliest Refusal

Score Breakdown

Violation Severity
67.8×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
56.1×10%
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

1185×

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).

754×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
2/20/2008
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
San Francisco District Office (SAN-DO)
2/20/2008
63VAJ99DEPIGMENTOR N.E.C.
118NOT LISTED
San Francisco District Office (SAN-DO)
1/26/2007
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
1/26/2007
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
1/26/2007
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
1/26/2007
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Guangzhou Baiyun District Yalu's FDA import refusal history?

Guangzhou Baiyun District Yalu (FEI: 3005291432) has 6 FDA import refusal record(s) in our database, spanning from 1/26/2007 to 2/20/2008.

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. Guangzhou Baiyun District Yalu's FEI number is 3005291432.

What types of violations has Guangzhou Baiyun District Yalu received?

Guangzhou Baiyun District Yalu 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 Guangzhou Baiyun District Yalu come from?

All FDA import refusal data for Guangzhou Baiyun District Yalu 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.