Two Way Trading Co.,
⚠️ Moderate Risk
FEI: 3003996590 • Kowloon • HONG KONG
FEI Number
3003996590
Location
Kowloon
Country
HONG KONGAddress
25 Parkes St.,, , Kowloon, , Hong Kong
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).
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.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/5/2012 | 61WDL99A-FUNGAL N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/23/2011 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 8/14/2008 | 54ECB99HERBALS & BOTANICAL TEAS, N.E.C. | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 10/3/2006 | 54ECB99HERBALS & BOTANICAL TEAS, N.E.C. | San Francisco District Office (SAN-DO) | |
| 6/20/2005 | 54ECB99HERBALS & BOTANICAL TEAS, N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/29/2004 | 60LAJ99ANALGESIC, N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/29/2004 | 66BBB99STIMULANT N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/22/2003 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Two Way Trading Co.,'s FDA import refusal history?
Two Way Trading Co., (FEI: 3003996590) has 8 FDA import refusal record(s) in our database, spanning from 7/22/2003 to 1/5/2012.
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. Two Way Trading Co.,'s FEI number is 3003996590.
What types of violations has Two Way Trading Co., received?
Two Way Trading Co., has been cited for 8 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 Two Way Trading Co., come from?
All FDA import refusal data for Two Way Trading Co., 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.