Tushar Remedies
⚠️ Moderate Risk
FEI: 3007915332 • Faridabad • INDIA
FEI Number
3007915332
Location
Faridabad
Country
INDIAAddress
129 Sector-7ALtdb 2, Sector 63ositeda, , Faridabad, , 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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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 |
|---|---|---|---|
| 12/4/2009 | 50NGY18HENNA | Southwest Import District Office (SWI-DO) | |
| 12/4/2009 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 12/4/2009 | 53LA09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Tushar Remedies's FDA import refusal history?
Tushar Remedies (FEI: 3007915332) has 3 FDA import refusal record(s) in our database, spanning from 12/4/2009 to 12/4/2009.
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. Tushar Remedies's FEI number is 3007915332.
What types of violations has Tushar Remedies received?
Tushar Remedies 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 Tushar Remedies come from?
All FDA import refusal data for Tushar Remedies 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.