Naka Sales Ltd
⚠️ Moderate Risk
FEI: 3000140492 • Etobicoke, ON • CANADA
FEI Number
3000140492
Location
Etobicoke, ON
Country
CANADAAddress
53 Queen's Plate Dr Unit #3, , Etobicoke, ON, Canada
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
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
SBGINSENG
The article is subject to refusal of admission in that it appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are not an herb or herbal ingredient derived from a plant classified within the genus Panax.
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.
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 |
|---|---|---|---|
| 9/12/2005 | 54FCL12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | New York District Office (NYK-DO) | |
| 9/12/2005 | 54FCL12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | New York District Office (NYK-DO) | |
| 9/12/2005 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 9/12/2005 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 4/13/2005 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 4/13/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/15/2003 | 54YYT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New York District Office (NYK-DO) | |
| 9/15/2003 | 54YYT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New York District Office (NYK-DO) | |
| 9/15/2003 | 54YYT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Naka Sales Ltd's FDA import refusal history?
Naka Sales Ltd (FEI: 3000140492) has 9 FDA import refusal record(s) in our database, spanning from 9/15/2003 to 9/12/2005.
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. Naka Sales Ltd's FEI number is 3000140492.
What types of violations has Naka Sales Ltd received?
Naka Sales Ltd has been cited for 7 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 Naka Sales Ltd come from?
All FDA import refusal data for Naka Sales Ltd 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.