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San Jiu Botanical Ltd.

⚠️ Moderate Risk

FEI: 3003644724 • Hong Kong • HONG KONG

FEI

FEI Number

3003644724

📍

Location

Hong Kong

🇭🇰

Country

HONG KONG
🏢

Address

Rm 2306b-9 Shun Tak Centre, West Tower, , Hong Kong, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

38.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
5
Unique Violations
9/25/2002
Latest Refusal
7/11/2002
Earliest Refusal

Score Breakdown

Violation Severity
71.4×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

162×

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.

752×

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).

23001×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

2491×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
9/25/2002
54EER99HERBALS & BOTANICAL TEAS, N.E.C.
16DIRECTIONS
75UNAPPROVED
Southwest Import District Office (SWI-DO)
9/25/2002
54EDR99HERBALS & BOTANICAL TEAS, N.E.C.
16DIRECTIONS
75UNAPPROVED
Southwest Import District Office (SWI-DO)
7/11/2002
54EDR99HERBALS & BOTANICAL TEAS, N.E.C.
2300DIETARYLBL
249FILTHY
482NUTRIT LBL
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is San Jiu Botanical Ltd.'s FDA import refusal history?

San Jiu Botanical Ltd. (FEI: 3003644724) has 3 FDA import refusal record(s) in our database, spanning from 7/11/2002 to 9/25/2002.

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. San Jiu Botanical Ltd.'s FEI number is 3003644724.

What types of violations has San Jiu Botanical Ltd. received?

San Jiu Botanical Ltd. has been cited for 5 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 San Jiu Botanical Ltd. come from?

All FDA import refusal data for San Jiu Botanical 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.