Plexus Manufacturing Sdn. Bhd.
⚠️ Moderate Risk
FEI: 3004593495 • Bayan Lepas, Pulau Pinang • MALAYSIA
FEI Number
3004593495
Location
Bayan Lepas, Pulau Pinang
Country
MALAYSIAAddress
Bayan Lepas Free Industrial Zone, Phase Ii, , Bayan Lepas, Pulau Pinang, 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
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/15/2023 | 74DTEPULSE-GENERATOR, PACEMAKER, EXTERNAL | Division of West Coast Imports (DWCI) | |
| 11/15/2023 | 74DTEPULSE-GENERATOR, PACEMAKER, EXTERNAL | Division of West Coast Imports (DWCI) | |
| 5/29/2008 | 74NVZPULSE GENERATOR, PERMANENT, IMPLANTABLE | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 5/29/2008 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 5/29/2008 | 74NVZPULSE GENERATOR, PERMANENT, IMPLANTABLE | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 5/29/2008 | 74NVZPULSE GENERATOR, PERMANENT, IMPLANTABLE | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 12/2/2002 | 73BZHMETER, PEAK FLOW, SPIROMETRY | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
| 12/2/2002 | 73BZHMETER, PEAK FLOW, SPIROMETRY | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Plexus Manufacturing Sdn. Bhd.'s FDA import refusal history?
Plexus Manufacturing Sdn. Bhd. (FEI: 3004593495) has 8 FDA import refusal record(s) in our database, spanning from 12/2/2002 to 11/15/2023.
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. Plexus Manufacturing Sdn. Bhd.'s FEI number is 3004593495.
What types of violations has Plexus Manufacturing Sdn. Bhd. received?
Plexus Manufacturing Sdn. Bhd. has been cited for 4 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 Plexus Manufacturing Sdn. Bhd. come from?
All FDA import refusal data for Plexus Manufacturing 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.