Landy International
⚠️ Moderate Risk
FEI: 3005698871 • Xia Men, Fujian • CHINA
FEI Number
3005698871
Location
Xia Men, Fujian
Country
CHINAAddress
No. 192 Tianfeng Road, Ji Mei District, Xia Men, Fujian, 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
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2020 | 62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 1/9/2009 | 53BD99OTHER BATH PREPARATIONS, N.E.C. | 11UNSAFE COL | New York District Office (NYK-DO) |
| 1/9/2009 | 53BD99OTHER BATH PREPARATIONS, N.E.C. | 11UNSAFE COL | New York District Office (NYK-DO) |
| 10/1/2008 | 53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 12/11/2007 | 53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Landy International's FDA import refusal history?
Landy International (FEI: 3005698871) has 5 FDA import refusal record(s) in our database, spanning from 12/11/2007 to 7/31/2020.
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. Landy International's FEI number is 3005698871.
What types of violations has Landy International received?
Landy International 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 Landy International come from?
All FDA import refusal data for Landy International 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.