Shree Swaminarayan Gurukul Herbal Aushadham
⚠️ Moderate Risk
FEI: 3014725989 • Rajkot, Gujarat • INDIA
FEI Number
3014725989
Location
Rajkot, Gujarat
Country
INDIAAddress
345 / 346 Gurukul Building, Gondal Road, Rajkot, Gujarat, India
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
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.
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.
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.
NCONTACT
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(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/1/2019 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southwest Imports (DSWI) | |
| 10/11/2019 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southwest Imports (DSWI) | |
| 10/11/2019 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southwest Imports (DSWI) | |
| 10/11/2019 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Shree Swaminarayan Gurukul Herbal Aushadham's FDA import refusal history?
Shree Swaminarayan Gurukul Herbal Aushadham (FEI: 3014725989) has 4 FDA import refusal record(s) in our database, spanning from 10/11/2019 to 11/1/2019.
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 Swaminarayan Gurukul Herbal Aushadham's FEI number is 3014725989.
What types of violations has Shree Swaminarayan Gurukul Herbal Aushadham received?
Shree Swaminarayan Gurukul Herbal Aushadham 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 Shree Swaminarayan Gurukul Herbal Aushadham come from?
All FDA import refusal data for Shree Swaminarayan Gurukul Herbal Aushadham 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.