AmLion Toothpaste Mfg Sdn
⚠️ High Risk
FEI: 3006057298 • Petaling Jaya, Selangor • MALAYSIA
FEI Number
3006057298
Location
Petaling Jaya, Selangor
Country
MALAYSIAAddress
Lot 4, Gate A, Jalan Teknologi 3/6, Seksyn 3, Taman Sains Selangor, Petaling Jaya, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/6/2025 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/10/2025 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/12/2023 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 9/25/2023 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/25/2023 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/25/2023 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/25/2023 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/25/2023 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/25/2023 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/25/2023 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/25/2023 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/25/2023 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/25/2023 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/25/2023 | 63RBG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 8/30/2018 | 63RBL04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is AmLion Toothpaste Mfg Sdn's FDA import refusal history?
AmLion Toothpaste Mfg Sdn (FEI: 3006057298) has 15 FDA import refusal record(s) in our database, spanning from 8/30/2018 to 11/6/2025.
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. AmLion Toothpaste Mfg Sdn's FEI number is 3006057298.
What types of violations has AmLion Toothpaste Mfg Sdn received?
AmLion Toothpaste Mfg Sdn 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 AmLion Toothpaste Mfg Sdn come from?
All FDA import refusal data for AmLion Toothpaste Mfg Sdn 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.