Sanjivni Herbal Care
⚠️ Moderate Risk
FEI: 3008766675 • Gujarat • INDIA
FEI Number
3008766675
Location
Gujarat
Country
INDIAAddress
Love Complex Opp Asara Cinema, , 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/9/2013 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 9/12/2012 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/7/2012 | 54YEB99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/1/2012 | 61PAY99ANTI-DIABETIC N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sanjivni Herbal Care's FDA import refusal history?
Sanjivni Herbal Care (FEI: 3008766675) has 4 FDA import refusal record(s) in our database, spanning from 8/1/2012 to 4/9/2013.
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. Sanjivni Herbal Care's FEI number is 3008766675.
What types of violations has Sanjivni Herbal Care received?
Sanjivni Herbal Care has been cited for 2 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 Sanjivni Herbal Care come from?
All FDA import refusal data for Sanjivni Herbal Care 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.