Beijing Tong Ren Tang Chinese Medicine Co., Ltd.
⚠️ Moderate Risk
FEI: 3009949292 • Beijing, Beijing • CHINA
FEI Number
3009949292
Location
Beijing, Beijing
Country
CHINAAddress
46 Xidamochangjie, , Beijing, Beijing, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/10/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 472NO ENGLISH | San Francisco District Office (SAN-DO) |
| 7/10/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 472NO ENGLISH | San Francisco District Office (SAN-DO) |
| 7/10/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 472NO ENGLISH | San Francisco District Office (SAN-DO) |
| 7/10/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/10/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/10/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 1/25/2006 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Beijing Tong Ren Tang Chinese Medicine Co., Ltd.'s FDA import refusal history?
Beijing Tong Ren Tang Chinese Medicine Co., Ltd. (FEI: 3009949292) has 7 FDA import refusal record(s) in our database, spanning from 1/25/2006 to 7/10/2007.
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 Chinese Medicine Co., Ltd.'s FEI number is 3009949292.
What types of violations has Beijing Tong Ren Tang Chinese Medicine Co., Ltd. received?
Beijing Tong Ren Tang Chinese Medicine Co., 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 Beijing Tong Ren Tang Chinese Medicine Co., Ltd. come from?
All FDA import refusal data for Beijing Tong Ren Tang Chinese Medicine 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.