U.S.A. International (Group)Holdings Company Limited
⚠️ Moderate Risk
FEI: 3004109661 • Hk • 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
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/14/2004 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 6/14/2004 | 53GH99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 6/14/2004 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 6/14/2004 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 6/14/2004 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 6/14/2004 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 6/14/2004 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 6/14/2004 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 6/14/2004 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 6/14/2004 | 21VFE14TAMARIND, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT | 320LACKS FIRM | Los Angeles District Office (LOS-DO) |
| 6/14/2004 | 21VFE14TAMARIND, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT | 320LACKS FIRM | Los Angeles District Office (LOS-DO) |
| 6/14/2004 | 53GD03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is U.S.A. International (Group)Holdings Company Limited's FDA import refusal history?
U.S.A. International (Group)Holdings Company Limited (FEI: 3004109661) has 12 FDA import refusal record(s) in our database, spanning from 6/14/2004 to 6/14/2004.
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. U.S.A. International (Group)Holdings Company Limited's FEI number is 3004109661.
What types of violations has U.S.A. International (Group)Holdings Company Limited received?
U.S.A. International (Group)Holdings Company Limited has been cited for 3 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 U.S.A. International (Group)Holdings Company Limited come from?
All FDA import refusal data for U.S.A. International (Group)Holdings Company Limited 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.