Bangkokbarrie Ltd.
⚠️ Moderate Risk
FEI: 3004443415 • Mueang Lampang, Lampang • THAILAND
FEI Number
3004443415
Location
Mueang Lampang, Lampang
Country
THAILANDAddress
14, Soi 4 Alley, Mueang Lampang, Lampang, 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).
COSM MISB2
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that its labeling is false or misleading in any particular.
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.
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 |
|---|---|---|---|
| 8/27/2005 | 66VBI99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/8/2005 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 3200COSM MISB2 | Cincinnati District Office (CIN-DO) |
| 8/8/2005 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 8/8/2005 | 64LAJ28FLUOCINONIDE (GLUCOCORTICOID) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/8/2005 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Bangkokbarrie Ltd.'s FDA import refusal history?
Bangkokbarrie Ltd. (FEI: 3004443415) has 5 FDA import refusal record(s) in our database, spanning from 8/8/2005 to 8/27/2005.
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. Bangkokbarrie Ltd.'s FEI number is 3004443415.
What types of violations has Bangkokbarrie Ltd. received?
Bangkokbarrie Ltd. has been cited for 4 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 Bangkokbarrie Ltd. come from?
All FDA import refusal data for Bangkokbarrie 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.