Northern Accord M Sdn Bhd
⚠️ Moderate Risk
FEI: 3005344114 • Johor • MALAYSIA
FEI Number
3005344114
Location
Johor
Country
MALAYSIAAddress
19 Jalan Sri Sulong Taman Indust, , Johor, , 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2005 | 55PG93EUCALYPTUS OIL (PHARMACEUTIC NECESSITY - FLAVOR) | Seattle District Office (SEA-DO) | |
| 10/27/2005 | 55PY97METHYL SALICYLATE (PHARMACEUTIC NECESSITY - FLAVOR) | Seattle District Office (SEA-DO) | |
| 10/26/2005 | 53LD11ARGAN OIL | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Northern Accord M Sdn Bhd's FDA import refusal history?
Northern Accord M Sdn Bhd (FEI: 3005344114) has 3 FDA import refusal record(s) in our database, spanning from 10/26/2005 to 11/3/2005.
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. Northern Accord M Sdn Bhd's FEI number is 3005344114.
What types of violations has Northern Accord M Sdn Bhd received?
Northern Accord M 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 Northern Accord M Sdn Bhd come from?
All FDA import refusal data for Northern Accord M 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.