Link Natural Products Private Ltd
⚠️ Moderate Risk
FEI: 3004609540 • Colombo • SRI LANKA
FEI Number
3004609540
Location
Colombo
Country
SRI LANKAAddress
Cic House 199 Kew Road, , Colombo, , Sri Lanka
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
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.
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/5/2020 | 54EYY99HERBALS & BOTANICAL TEAS, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 6/5/2020 | 54EYY99HERBALS & BOTANICAL TEAS, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/18/2018 | 54EYY99HERBALS & BOTANICAL TEAS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/10/2018 | 54EYY99HERBALS & BOTANICAL TEAS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/14/2017 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/21/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 7/1/2008 | 31KFT99TEA, N.E.C. | 260FALSE | New Orleans District Office (NOL-DO) |
| 4/8/2008 | 54ACY99VITAMIN, N.E.C. | 488HEALTH C | New Orleans District Office (NOL-DO) |
| 4/8/2008 | 54ACY99VITAMIN, N.E.C. | 488HEALTH C | New Orleans District Office (NOL-DO) |
| 4/8/2008 | 54ACY99VITAMIN, N.E.C. | 488HEALTH C | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Link Natural Products Private Ltd's FDA import refusal history?
Link Natural Products Private Ltd (FEI: 3004609540) has 10 FDA import refusal record(s) in our database, spanning from 4/8/2008 to 6/5/2020.
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. Link Natural Products Private Ltd's FEI number is 3004609540.
What types of violations has Link Natural Products Private Ltd received?
Link Natural Products Private Ltd has been cited for 6 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 Link Natural Products Private Ltd come from?
All FDA import refusal data for Link Natural Products Private 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.