Cosmelor Ltd.
⚠️ Moderate Risk
FEI: 1000189112 • Minato, Tokyo • JAPAN
FEI Number
1000189112
Location
Minato, Tokyo
Country
JAPANAddress
2 Chome 4-5, Azabudai, Minato, Tokyo, Japan
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/8/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/29/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/29/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/29/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/16/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 7/29/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 7/29/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 7/29/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 7/29/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 7/15/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 7/6/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 7/6/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 6/21/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/21/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/21/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/21/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/14/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/12/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/12/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/12/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/12/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/12/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/12/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/12/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/12/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/12/2002 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/27/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 4/27/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 2/27/2002 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/17/2001 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/17/2001 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 11/7/2001 | 66PBR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Cosmelor Ltd.'s FDA import refusal history?
Cosmelor Ltd. (FEI: 1000189112) has 32 FDA import refusal record(s) in our database, spanning from 11/7/2001 to 11/8/2002.
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. Cosmelor Ltd.'s FEI number is 1000189112.
What types of violations has Cosmelor Ltd. received?
Cosmelor Ltd. has been cited for 1 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 Cosmelor Ltd. come from?
All FDA import refusal data for Cosmelor 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.