POLENS (M) Sdn Bhd
⚠️ Moderate Risk
FEI: 3004657398 • Shah Alam, MY-10 • MALAYSIA
FEI Number
3004657398
Location
Shah Alam, MY-10
Country
MALAYSIAAddress
No 1, Jalan Saham 23/3, Section 23, Shah Alam, MY-10, Malaysia
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).
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(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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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 PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/24/2013 | 54FBE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/7/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 5/9/2005 | 24DEF14STRINGBEANS (GREEN, SNAP, POLE), JUICE OR DRINK | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is POLENS (M) Sdn Bhd's FDA import refusal history?
POLENS (M) Sdn Bhd (FEI: 3004657398) has 3 FDA import refusal record(s) in our database, spanning from 5/9/2005 to 6/24/2013.
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. POLENS (M) Sdn Bhd's FEI number is 3004657398.
What types of violations has POLENS (M) Sdn Bhd received?
POLENS (M) Sdn Bhd has been cited for 7 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 POLENS (M) Sdn Bhd come from?
All FDA import refusal data for POLENS (M) Sdn Bhd 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.