Nutraland Limited
⚠️ Moderate Risk
FEI: 3005068563 • Shanghai, Shanghai • CHINA
FEI Number
3005068563
Location
Shanghai, Shanghai
Country
CHINAAddress
Building C Office 2404, No. 70 Caobao Road, Shanghai, Shanghai, China
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).
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
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.
HEALTH C
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 bears an unauthorized nutrient content/health claim.
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).
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.
SACCHARIN
The article contains Saccharin, a non-nutritive sweetner, and its label or labeling fails to bear the required warning statement.
CYCLAMATE
The article appears to bear or contain cyclamate, an unsafe food additive within the meaning of Section 409
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
DULCIN
The article appears to bear or contain dulcin, an unsafe food additive within the meaning of Section 409
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/25/2014 | 54YBZ99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 11/25/2011 | 54AIZ18VITAMIN K (PHYTONADIONE) | New Orleans District Office (NOL-DO) | |
| 11/25/2011 | 65JAR31PROGESTERONE (PROGESTIN) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/18/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 11/18/2010 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/10/2008 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 488HEALTH C | New Orleans District Office (NOL-DO) |
| 9/10/2008 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 488HEALTH C | New Orleans District Office (NOL-DO) |
| 9/10/2008 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 9/10/2008 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 8/12/2008 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 1/5/2007 | 20BVH02BLUEBERRIES, DRIED OR PASTE | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Nutraland Limited's FDA import refusal history?
Nutraland Limited (FEI: 3005068563) has 11 FDA import refusal record(s) in our database, spanning from 1/5/2007 to 3/25/2014.
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. Nutraland Limited's FEI number is 3005068563.
What types of violations has Nutraland Limited received?
Nutraland Limited has been cited for 15 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 Nutraland Limited come from?
All FDA import refusal data for Nutraland Limited 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.