Prime Herbal Health Care
⚠️ Moderate Risk
FEI: 3003664948 • Rampur, Punjab • INDIA
FEI Number
3003664948
Location
Rampur, Punjab
Country
INDIAAddress
J - 12/7 Gobind Colony, , Rampur, Punjab, 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).
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.
HEALTH C
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 bears an unauthorized nutrient content/health claim.
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/10/2023 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/18/2011 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 4/18/2011 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 4/18/2011 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 12/29/2005 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 8/25/2004 | 54FCH30AGRIMONY (HERBAL & BOTANICALS, NOT TEAS) | Los Angeles District Office (LOS-DO) | |
| 8/25/2004 | 54FCL30AGRIMONY (HERBAL & BOTANICALS, NOT TEAS) | Los Angeles District Office (LOS-DO) | |
| 8/25/2004 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2300DIETARYLBL | Los Angeles District Office (LOS-DO) |
| 8/25/2004 | 54FCL30AGRIMONY (HERBAL & BOTANICALS, NOT TEAS) | 488HEALTH C | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Prime Herbal Health Care's FDA import refusal history?
Prime Herbal Health Care (FEI: 3003664948) has 9 FDA import refusal record(s) in our database, spanning from 8/25/2004 to 10/10/2023.
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 Herbal Health Care's FEI number is 3003664948.
What types of violations has Prime Herbal Health Care received?
Prime Herbal Health Care has been cited for 5 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 Herbal Health Care come from?
All FDA import refusal data for Prime Herbal Health 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.