STRAITS ORTHOPAEDICS (MFG) SDN BHD
⚠️ Moderate Risk
FEI: 3012217062 • Perai, Pulau Pinang • MALAYSIA
FEI Number
3012217062
Location
Perai, Pulau Pinang
Country
MALAYSIAAddress
Perai Free Industrial Zone, No 2483 Tingkat Perusahaan 4a, Perai, 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
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).
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).
Refusal History
Frequently Asked Questions
What is STRAITS ORTHOPAEDICS (MFG) SDN BHD's FDA import refusal history?
STRAITS ORTHOPAEDICS (MFG) SDN BHD (FEI: 3012217062) has 1 FDA import refusal record(s) in our database, spanning from 8/22/2025 to 8/22/2025.
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. STRAITS ORTHOPAEDICS (MFG) SDN BHD's FEI number is 3012217062.
What types of violations has STRAITS ORTHOPAEDICS (MFG) SDN BHD received?
STRAITS ORTHOPAEDICS (MFG) 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 STRAITS ORTHOPAEDICS (MFG) SDN BHD come from?
All FDA import refusal data for STRAITS ORTHOPAEDICS (MFG) 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.