Genius Nature Herbs Pvt
⚠️ High Risk
FEI: 3009619398 • Coimbatore • INDIA
FEI Number
3009619398
Location
Coimbatore
Country
INDIAAddress
195 Officers Colony Peur Pachapalyam, , Coimbatore, , India
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
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).
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).
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.
INCONSPICU
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)).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/25/2013 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 5/14/2013 | 54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/6/2013 | 54K10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/3/2013 | 54KYY10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/29/2013 | 54KBY10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/29/2013 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 4/19/2013 | 54KYY10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/6/2013 | 54JYY10MORINGA OLEIFERA (HERBAL AND BOTANICAL TEAS II, (CONTINUED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/6/2013 | 54JYY10MORINGA OLEIFERA (HERBAL AND BOTANICAL TEAS II, (CONTINUED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/27/2013 | 54KYY10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/22/2013 | 54KYY10MORINGA OLEIFERA (HERBAL AND BOTANICAL (NOT TEAS II) CONTD | 256INCONSPICU | Cincinnati District Office (CIN-DO) |
| 11/13/2012 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 256INCONSPICU | Cincinnati District Office (CIN-DO) |
| 11/13/2012 | 62VCY99ANTI-VIRAL N.E.C. | Cincinnati District Office (CIN-DO) | |
| 11/13/2012 | 62VCR99ANTI-VIRAL N.E.C. | Cincinnati District Office (CIN-DO) | |
| 11/13/2012 | 62VCY99ANTI-VIRAL N.E.C. | Cincinnati District Office (CIN-DO) | |
| 11/13/2012 | 62VCR99ANTI-VIRAL N.E.C. | Cincinnati District Office (CIN-DO) | |
| 11/13/2012 | 62VCH99ANTI-VIRAL N.E.C. | Cincinnati District Office (CIN-DO) | |
| 11/13/2012 | 62VCA99ANTI-VIRAL N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Genius Nature Herbs Pvt's FDA import refusal history?
Genius Nature Herbs Pvt (FEI: 3009619398) has 18 FDA import refusal record(s) in our database, spanning from 11/13/2012 to 6/25/2013.
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. Genius Nature Herbs Pvt's FEI number is 3009619398.
What types of violations has Genius Nature Herbs Pvt received?
Genius Nature Herbs Pvt 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 Genius Nature Herbs Pvt come from?
All FDA import refusal data for Genius Nature Herbs Pvt 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.