SHREE DHANWANTRI HERBALS PRIVATE LIMITED
⚠️ High Risk
FEI: 3017150060 • AMRITSAR, Punjab • INDIA
FEI Number
3017150060
Location
AMRITSAR, Punjab
Country
INDIAAddress
Hadbast No. 334, Shree Dhanwantri Herbals, Majitha Road, VPO Nag Kalan, AMRITSAR, Punjab, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2025 | 54FGY94ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/17/2025 | 61XCA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/31/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 7/29/2025 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/24/2025 | 66YBJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 473LABELING | Division of Northeast Imports (DNEI) |
| 6/24/2025 | 66YBR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 473LABELING | Division of Northeast Imports (DNEI) |
| 1/3/2025 | 54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/19/2024 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 6/12/2023 | 54FGE94ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/1/2023 | 62VDY99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2023 | 66CDY99STOOL SOFTENER N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/13/2022 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is SHREE DHANWANTRI HERBALS PRIVATE LIMITED's FDA import refusal history?
SHREE DHANWANTRI HERBALS PRIVATE LIMITED (FEI: 3017150060) has 13 FDA import refusal record(s) in our database, spanning from 10/13/2022 to 12/20/2025.
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. SHREE DHANWANTRI HERBALS PRIVATE LIMITED's FEI number is 3017150060.
What types of violations has SHREE DHANWANTRI HERBALS PRIVATE LIMITED received?
SHREE DHANWANTRI HERBALS PRIVATE LIMITED 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 SHREE DHANWANTRI HERBALS PRIVATE LIMITED come from?
All FDA import refusal data for SHREE DHANWANTRI HERBALS PRIVATE 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.