Bertram Chemical (1982) Company Limited
⚠️ Moderate Risk
FEI: 3004634418 • Lam Luk Ka, Pathum Thani • THAILAND
FEI Number
3004634418
Location
Lam Luk Ka, Pathum Thani
Country
THAILANDAddress
1, Bueng Kham Proi, Lam Luk Ka, Pathum Thani, 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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/4/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 8/4/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 2/16/2012 | 62MBJ08MENTHOL (ANTI-PRURITIC) | New York District Office (NYK-DO) | |
| 3/17/2011 | 53DD99OTHER FRAGRANCE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 3/17/2011 | 53DD99OTHER FRAGRANCE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 8/8/2007 | 62MBL08MENTHOL (ANTI-PRURITIC) | Los Angeles District Office (LOS-DO) | |
| 8/8/2007 | 62MBO08MENTHOL (ANTI-PRURITIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/27/2004 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Bertram Chemical (1982) Company Limited's FDA import refusal history?
Bertram Chemical (1982) Company Limited (FEI: 3004634418) has 8 FDA import refusal record(s) in our database, spanning from 9/27/2004 to 8/4/2016.
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. Bertram Chemical (1982) Company Limited's FEI number is 3004634418.
What types of violations has Bertram Chemical (1982) Company Limited received?
Bertram Chemical (1982) Company Limited 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 Bertram Chemical (1982) Company Limited come from?
All FDA import refusal data for Bertram Chemical (1982) 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.