Multisafe Sdn. Bhd.
⚠️ Moderate Risk
FEI: 3004360380 • Batang Padang, Perak • MALAYSIA
FEI Number
3004360380
Location
Batang Padang, Perak
Country
MALAYSIAAddress
Lot 764, Jalan Besar Bidor, Batang Padang, Perak, 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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.
POSS N/STR
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/26/2021 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 10/26/2021 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | Division of Northern Border Imports (DNBI) | |
| 9/18/2014 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 2800POSS N/STR | New York District Office (NYK-DO) |
| 4/29/2014 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 10/12/2010 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 8/19/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Multisafe Sdn. Bhd.'s FDA import refusal history?
Multisafe Sdn. Bhd. (FEI: 3004360380) has 6 FDA import refusal record(s) in our database, spanning from 8/19/2009 to 10/26/2021.
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. Multisafe Sdn. Bhd.'s FEI number is 3004360380.
What types of violations has Multisafe Sdn. Bhd. received?
Multisafe Sdn. Bhd. has been cited for 6 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 Multisafe Sdn. Bhd. come from?
All FDA import refusal data for Multisafe 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.