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BEIJING TONGRETANG CHINESE MEDICINAL HERBAL REFINERY

⚠️ Moderate Risk

FEI: 3002448564 • Beijing, Beijing • CHINA

FEI

FEI Number

3002448564

📍

Location

Beijing, Beijing

🇨🇳

Country

CHINA
🏢

Address

130 Xizhimen Beishunchengjie, , Beijing, Beijing, China

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
8/15/2003
Latest Refusal
8/15/2003
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

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).

Refusal History

DateProductViolationsDivision
8/15/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)
8/15/2003
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is BEIJING TONGRETANG CHINESE MEDICINAL HERBAL REFINERY's FDA import refusal history?

BEIJING TONGRETANG CHINESE MEDICINAL HERBAL REFINERY (FEI: 3002448564) has 2 FDA import refusal record(s) in our database, spanning from 8/15/2003 to 8/15/2003.

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. BEIJING TONGRETANG CHINESE MEDICINAL HERBAL REFINERY's FEI number is 3002448564.

What types of violations has BEIJING TONGRETANG CHINESE MEDICINAL HERBAL REFINERY received?

BEIJING TONGRETANG CHINESE MEDICINAL HERBAL REFINERY has been cited for 1 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 BEIJING TONGRETANG CHINESE MEDICINAL HERBAL REFINERY come from?

All FDA import refusal data for BEIJING TONGRETANG CHINESE MEDICINAL HERBAL REFINERY 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.