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BEIJING TONG REN TANG HEALTH PHARMA

⚠️ Moderate Risk

FEI: 3016947788 • Beijing • CHINA

FEI

FEI Number

3016947788

📍

Location

Beijing

🇨🇳

Country

CHINA
🏢

Address

Bldg 58 F 5-13, 2 Jingyuan N Str; Dvpt Zone, Beijing, , China

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/7/2020
Latest Refusal
7/7/2020
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

751×

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
7/7/2020
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BEIJING TONG REN TANG HEALTH PHARMA's FDA import refusal history?

BEIJING TONG REN TANG HEALTH PHARMA (FEI: 3016947788) has 1 FDA import refusal record(s) in our database, spanning from 7/7/2020 to 7/7/2020.

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 TONG REN TANG HEALTH PHARMA's FEI number is 3016947788.

What types of violations has BEIJING TONG REN TANG HEALTH PHARMA received?

BEIJING TONG REN TANG HEALTH PHARMA 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 BEIJING TONG REN TANG HEALTH PHARMA come from?

All FDA import refusal data for BEIJING TONG REN TANG HEALTH PHARMA 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.