Tianjin Medicines & Health Products Import & Export Corp.
⚠️ Moderate Risk
FEI: 3002468384 • Tianjin, Tianjin • CHINA
FEI Number
3002468384
Location
Tianjin, Tianjin
Country
CHINAAddress
Hai Tai Information Square, Hi-Tech Indu, Building C 5th Floor; NO. 8 Huatiandao, Tianjin, Tianjin, 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).
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
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.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/22/2021 | 61XBA99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2013 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 3/27/2013 | 65PCA04VARDENAFIL | Division of Northern Border Imports (DNBI) | |
| 3/27/2013 | 65PCA04VARDENAFIL | Division of Northern Border Imports (DNBI) | |
| 5/4/2011 | 21HGH16CHINESE RED DATE (JUJUBES, ZIZIPHUS JUJUBA), DRIED OR PASTE | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 1/6/2009 | 54AEH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | New Orleans District Office (NOL-DO) | |
| 8/15/2005 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Detroit District Office (DET-DO) | |
| 8/7/2003 | 68YAS10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Tianjin Medicines & Health Products Import & Export Corp.'s FDA import refusal history?
Tianjin Medicines & Health Products Import & Export Corp. (FEI: 3002468384) has 8 FDA import refusal record(s) in our database, spanning from 8/7/2003 to 4/22/2021.
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. Tianjin Medicines & Health Products Import & Export Corp.'s FEI number is 3002468384.
What types of violations has Tianjin Medicines & Health Products Import & Export Corp. received?
Tianjin Medicines & Health Products Import & Export Corp. has been cited for 12 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 Tianjin Medicines & Health Products Import & Export Corp. come from?
All FDA import refusal data for Tianjin Medicines & Health Products Import & Export Corp. 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.