Beijing Tong Ren Tang Technologies Co. Ltd.
⚠️ Moderate Risk
FEI: 3006785564 • Beijing, Beijing • CHINA
FEI Number
3006785564
Location
Beijing, Beijing
Country
CHINAAddress
No. 20 Nansanhuan Central Road, Fengtai, 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
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).
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.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2015 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-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) | |
| 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) | |
| 7/10/2007 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 6/15/2004 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Beijing Tong Ren Tang Technologies Co. Ltd.'s FDA import refusal history?
Beijing Tong Ren Tang Technologies Co. Ltd. (FEI: 3006785564) has 10 FDA import refusal record(s) in our database, spanning from 6/15/2004 to 9/29/2015.
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 Technologies Co. Ltd.'s FEI number is 3006785564.
What types of violations has Beijing Tong Ren Tang Technologies Co. Ltd. received?
Beijing Tong Ren Tang Technologies Co. Ltd. has been cited for 6 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 Technologies Co. Ltd. come from?
All FDA import refusal data for Beijing Tong Ren Tang Technologies 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.