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China Tea & Herbalworld (Hong Kong) Co Ltd

⚠️ High Risk

FEI: 3009088071 • Kwum Tong • HONG KONG

FEI

FEI Number

3009088071

📍

Location

Kwum Tong

🇭🇰

Country

HONG KONG
🏢

Address

13f Houtex Industrial Bldg 16 Hung To Rd, , Kwum Tong, , Hong Kong

High Risk

FDA Import Risk Assessment

51.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

7
Total Refusals
2
Unique Violations
12/11/2012
Latest Refusal
12/11/2012
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

757×

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).

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).

Refusal History

DateProductViolationsDivision
12/11/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)
12/11/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)
12/11/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)
12/11/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)
12/11/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)
12/11/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)
12/11/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is China Tea & Herbalworld (Hong Kong) Co Ltd's FDA import refusal history?

China Tea & Herbalworld (Hong Kong) Co Ltd (FEI: 3009088071) has 7 FDA import refusal record(s) in our database, spanning from 12/11/2012 to 12/11/2012.

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. China Tea & Herbalworld (Hong Kong) Co Ltd's FEI number is 3009088071.

What types of violations has China Tea & Herbalworld (Hong Kong) Co Ltd received?

China Tea & Herbalworld (Hong Kong) Co Ltd 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 China Tea & Herbalworld (Hong Kong) Co Ltd come from?

All FDA import refusal data for China Tea & Herbalworld (Hong Kong) 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.