WRP Asia Pacific Sdn Bhd
⚠️ Moderate Risk
FEI: 3002808507 • Sepang, Selangor • MALAYSIA
FEI Number
3002808507
Location
Sepang, Selangor
Country
MALAYSIAAddress
Lot 1, Jalan 3, Sepang, Selangor, 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.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
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(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/23/2021 | 80FMCGLOVE, PATIENT EXAMINATION | Division of Southeast Imports (DSEI) | |
| 2/26/2021 | 80FMCGLOVE, PATIENT EXAMINATION | Division of Southeast Imports (DSEI) | |
| 3/30/2016 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 3/30/2016 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 11/20/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 11/19/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | San Francisco District Office (SAN-DO) |
| 9/27/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 12/1/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Chicago District Office (CHI-DO) |
| 12/1/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Chicago District Office (CHI-DO) |
| 12/1/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Chicago District Office (CHI-DO) |
| 12/1/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Chicago District Office (CHI-DO) |
| 9/22/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Chicago District Office (CHI-DO) |
| 9/22/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Chicago District Office (CHI-DO) |
| 9/22/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Chicago District Office (CHI-DO) |
| 9/11/2006 | 80NPDSURGEON'S GLOVES, POWDER FREE | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/11/2006 | 80NPDSURGEON'S GLOVES, POWDER FREE | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/21/2003 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Chicago District Office (CHI-DO) |
| 2/21/2003 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Chicago District Office (CHI-DO) |
| 1/16/2003 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is WRP Asia Pacific Sdn Bhd's FDA import refusal history?
WRP Asia Pacific Sdn Bhd (FEI: 3002808507) has 21 FDA import refusal record(s) in our database, spanning from 1/16/2003 to 3/23/2021.
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. WRP Asia Pacific Sdn Bhd's FEI number is 3002808507.
What types of violations has WRP Asia Pacific Sdn Bhd received?
WRP Asia Pacific 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 WRP Asia Pacific Sdn Bhd come from?
All FDA import refusal data for WRP Asia Pacific 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.