HINDUSTAN HERBAL COSMETICS
⚠️ Moderate Risk
FEI: 3012364577 • Noida, Uttar Pradesh • INDIA
FEI Number
3012364577
Location
Noida, Uttar Pradesh
Country
INDIAAddress
F-457, 2nd & 3rd Floor, Sector-63, , Noida, Uttar Pradesh, 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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
NOCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be a nonprescription drug that is misbranded within the meaning of Section 502(x) of the FD&C Act in that the product label fails to bear a domestic address or phone number through which the responsible person may receive a report of a serious adverse event with such drug.
NONRX505G
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it appears to be misbranded within the meaning of section 502(ee) of the FD&C Act, under which a drug is deemed to be misbranded if it is a nonprescription drug that is subject to section 505G of the FD&C Act but does not comply with the requirements for marketing under said section 505G and is not the subject of an application approved under section 505 of the FD&C Act.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/23/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 3/23/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is HINDUSTAN HERBAL COSMETICS's FDA import refusal history?
HINDUSTAN HERBAL COSMETICS (FEI: 3012364577) has 2 FDA import refusal record(s) in our database, spanning from 3/23/2021 to 3/23/2021.
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. HINDUSTAN HERBAL COSMETICS's FEI number is 3012364577.
What types of violations has HINDUSTAN HERBAL COSMETICS received?
HINDUSTAN HERBAL COSMETICS has been cited for 7 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 HINDUSTAN HERBAL COSMETICS come from?
All FDA import refusal data for HINDUSTAN HERBAL COSMETICS 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.