Ansell Shah Alam Sdn Bhd
⚠️ High Risk
FEI: 3003151251 • Selangor Darul Ehsan, Selangor • MALAYSIA
FEI Number
3003151251
Location
Selangor Darul Ehsan, Selangor
Country
MALAYSIAAddress
Lot 16, Persiaran Perusahaan, Section 23, Shah Alam, Selangor Darul Ehsan, Selangor, Malaysia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/10/2003 | 79KGOSURGEON'S GLOVES | 477HOLES | Atlanta District Office (ATL-DO) |
| 7/10/2003 | 79KGOSURGEON'S GLOVES | 477HOLES | Atlanta District Office (ATL-DO) |
| 7/10/2003 | 79KGOSURGEON'S GLOVES | 477HOLES | Atlanta District Office (ATL-DO) |
| 7/10/2003 | 79KGOSURGEON'S GLOVES | 477HOLES | Atlanta District Office (ATL-DO) |
| 7/10/2003 | 79KGOSURGEON'S GLOVES | 477HOLES | Atlanta District Office (ATL-DO) |
| 7/10/2003 | 79KGOSURGEON'S GLOVES | 477HOLES | Atlanta District Office (ATL-DO) |
| 12/10/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 12/10/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 12/3/2002 | 79KGOSURGEON'S GLOVES | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 12/3/2002 | 79KGOSURGEON'S GLOVES | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/12/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 477HOLES | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 79KGOSURGEON'S GLOVES | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 126FAILS STD | Southwest Import District Office (SWI-DO) |
| 11/7/2002 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 126FAILS STD | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Ansell Shah Alam Sdn Bhd's FDA import refusal history?
Ansell Shah Alam Sdn Bhd (FEI: 3003151251) has 39 FDA import refusal record(s) in our database, spanning from 11/7/2002 to 7/10/2003.
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. Ansell Shah Alam Sdn Bhd's FEI number is 3003151251.
What types of violations has Ansell Shah Alam Sdn Bhd received?
Ansell Shah Alam Sdn Bhd has been cited for 2 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 Ansell Shah Alam Sdn Bhd come from?
All FDA import refusal data for Ansell Shah Alam 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.