COSMAPROF COMPANY LIMITED
⚠️ Moderate Risk
FEI: 3008220947 • Bang Kapi, Bangkok • THAILAND
FEI Number
3008220947
Location
Bang Kapi, Bangkok
Country
THAILANDAddress
42,44,46 Ramkhamhaeng Road, Soi Ramkhamhaeng 60/3, Bang Kapi, Bangkok, Thailand
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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.
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 |
|---|---|---|---|
| 3/20/2018 | 64XBY06SALICYLIC ACID (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 8/2/2017 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/2/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/2/2017 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/2/2017 | 53MD01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/2/2017 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/2/2017 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/29/2015 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 7/29/2015 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 4/2/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 2/28/2013 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 2/28/2013 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is COSMAPROF COMPANY LIMITED's FDA import refusal history?
COSMAPROF COMPANY LIMITED (FEI: 3008220947) has 12 FDA import refusal record(s) in our database, spanning from 2/28/2013 to 3/20/2018.
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. COSMAPROF COMPANY LIMITED's FEI number is 3008220947.
What types of violations has COSMAPROF COMPANY LIMITED received?
COSMAPROF COMPANY LIMITED 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 COSMAPROF COMPANY LIMITED come from?
All FDA import refusal data for COSMAPROF 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.