Herbolab India Pvt Ltd
⚠️ Moderate Risk
FEI: 3013587456 • Silvassa, Dadra And Nagar Haveli • INDIA
FEI Number
3013587456
Location
Silvassa, Dadra And Nagar Haveli
Country
INDIAAddress
Gala No. 65-72, 'D' Wing, 1st Floor,, Span Industrial Complex, Silvassa, Dadra And Nagar Haveli, 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).
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 |
|---|---|---|---|
| 8/17/2021 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2021 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2017 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 260FALSE | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Herbolab India Pvt Ltd's FDA import refusal history?
Herbolab India Pvt Ltd (FEI: 3013587456) has 3 FDA import refusal record(s) in our database, spanning from 12/29/2017 to 8/17/2021.
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. Herbolab India Pvt Ltd's FEI number is 3013587456.
What types of violations has Herbolab India Pvt Ltd received?
Herbolab India Pvt Ltd 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 Herbolab India Pvt Ltd come from?
All FDA import refusal data for Herbolab India Pvt 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.