Hsahnaz Herbals
⚠️ Moderate Risk
FEI: 3005837633 • New Delhi, Delhi • INDIA
FEI Number
3005837633
Location
New Delhi, Delhi
Country
INDIAAddress
C - 42, , New Delhi, Delhi, 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
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.
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 COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each 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 |
|---|---|---|---|
| 10/22/2007 | 56GBL99ANTIFUNGAL N.E.C. | San Francisco District Office (SAN-DO) | |
| 10/22/2007 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 10/22/2007 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | San Francisco District Office (SAN-DO) | |
| 10/22/2007 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 10/22/2007 | 57NY02CELL & GENE THERAPIES (HUMAN TISSUE, CELLULAR THERAPIES) | San Francisco District Office (SAN-DO) | |
| 10/22/2007 | 66YAJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 10/22/2007 | 66YAJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 10/22/2007 | 66YAJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | San Francisco District Office (SAN-DO) | |
| 10/22/2007 | 63VBJ99DEPIGMENTOR N.E.C. | San Francisco District Office (SAN-DO) | |
| 10/22/2007 | 65GAL99PIGMENTATION AGENT N.E.C. | San Francisco District Office (SAN-DO) | |
| 10/22/2007 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | San Francisco District Office (SAN-DO) | |
| 8/24/2007 | 53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 471CSTIC LBLG | San Francisco District Office (SAN-DO) |
| 8/24/2007 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | San Francisco District Office (SAN-DO) | |
| 8/24/2007 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 8/24/2007 | 53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 8/24/2007 | 53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Hsahnaz Herbals's FDA import refusal history?
Hsahnaz Herbals (FEI: 3005837633) has 16 FDA import refusal record(s) in our database, spanning from 8/24/2007 to 10/22/2007.
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. Hsahnaz Herbals's FEI number is 3005837633.
What types of violations has Hsahnaz Herbals received?
Hsahnaz Herbals 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 Hsahnaz Herbals come from?
All FDA import refusal data for Hsahnaz Herbals 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.