Prime Herbonix Health Products Pvt Ltd
⚠️ High Risk
FEI: 3008374160 • Maharashtra • INDIA
FEI Number
3008374160
Location
Maharashtra
Country
INDIAAddress
Suite No.63 Patil Arado, , Maharashtra, , 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).
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 54FYF99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | New York District Office (NYK-DO) | |
| 1/10/2011 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2010 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 482NUTRIT LBL | Seattle District Office (SEA-DO) |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 482NUTRIT LBL | Seattle District Office (SEA-DO) |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 482NUTRIT LBL | Seattle District Office (SEA-DO) |
| 9/21/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Seattle District Office (SEA-DO) |
| 9/21/2010 | 54FEJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 9/21/2010 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 9/21/2010 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Prime Herbonix Health Products Pvt Ltd's FDA import refusal history?
Prime Herbonix Health Products Pvt Ltd (FEI: 3008374160) has 45 FDA import refusal record(s) in our database, spanning from 9/21/2010 to 1/10/2011.
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. Prime Herbonix Health Products Pvt Ltd's FEI number is 3008374160.
What types of violations has Prime Herbonix Health Products Pvt Ltd received?
Prime Herbonix Health Products Pvt Ltd 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 Prime Herbonix Health Products Pvt Ltd come from?
All FDA import refusal data for Prime Herbonix Health Products 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.