Hemma Herbs Pvt Ltd
⚠️ Moderate Risk
FEI: 3008702055 • Kolkata • INDIA
FEI Number
3008702055
Location
Kolkata
Country
INDIAAddress
Plot-39, Industrial Area, , Kolkata, , 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).
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).
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
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.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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 |
|---|---|---|---|
| 2/12/2016 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | San Francisco District Office (SAN-DO) | |
| 3/28/2014 | 54YEY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New England District Office (NWE-DO) | |
| 4/6/2012 | 54AER99VITAMIN, N.E.C. | New Orleans District Office (NOL-DO) | |
| 11/24/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 11/4/2010 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Minneapolis District Office (MIN-DO) | |
| 5/24/2007 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Hemma Herbs Pvt Ltd's FDA import refusal history?
Hemma Herbs Pvt Ltd (FEI: 3008702055) has 6 FDA import refusal record(s) in our database, spanning from 5/24/2007 to 2/12/2016.
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. Hemma Herbs Pvt Ltd's FEI number is 3008702055.
What types of violations has Hemma Herbs Pvt Ltd received?
Hemma Herbs Pvt Ltd has been cited for 8 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 Hemma Herbs Pvt Ltd come from?
All FDA import refusal data for Hemma Herbs 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.