B.C. Cosmetic Co.,Ltd.
⚠️ Moderate Risk
FEI: 3007178677 • Bangkok • THAILAND
FEI Number
3007178677
Location
Bangkok
Country
THAILANDAddress
1095 Charoen Krung Road, , 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
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).
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/29/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 5/1/2015 | 55P70CETYL ALCOHOL (PHARMACEUTIC NECESSITY - EMULSIFYING & STIFFENING AGENT) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/4/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 5/23/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 11/25/2009 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/25/2009 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/4/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/4/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/4/2009 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is B.C. Cosmetic Co.,Ltd.'s FDA import refusal history?
B.C. Cosmetic Co.,Ltd. (FEI: 3007178677) has 9 FDA import refusal record(s) in our database, spanning from 11/4/2009 to 12/29/2015.
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. B.C. Cosmetic Co.,Ltd.'s FEI number is 3007178677.
What types of violations has B.C. Cosmetic Co.,Ltd. received?
B.C. Cosmetic Co.,Ltd. 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 B.C. Cosmetic Co.,Ltd. come from?
All FDA import refusal data for B.C. Cosmetic Co.,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.