Borden Company (Private) Limited
⚠️ Moderate Risk
FEI: 3003754256 • Singapore • SINGAPORE
FEI Number
3003754256
Location
Singapore
Country
SINGAPOREAddress
No. 9 Jalan Kilang, #06-01 Borden Centre, Singapore, , Singapore
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).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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.
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/26/2005 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 8/15/2005 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 8/15/2005 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) | |
| 3/8/2005 | 62MBL08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/28/2002 | 62MBL08MENTHOL (ANTI-PRURITIC) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Borden Company (Private) Limited's FDA import refusal history?
Borden Company (Private) Limited (FEI: 3003754256) has 5 FDA import refusal record(s) in our database, spanning from 6/28/2002 to 10/26/2005.
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. Borden Company (Private) Limited's FEI number is 3003754256.
What types of violations has Borden Company (Private) Limited received?
Borden Company (Private) 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 Borden Company (Private) Limited come from?
All FDA import refusal data for Borden Company (Private) 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.