Bharat Enterprises
⚠️ Moderate Risk
FEI: 3008510717 • Maharashtra • INDIA
FEI Number
3008510717
Location
Maharashtra
Country
INDIAAddress
7 Sai Niwas Laxmi Bldg 116 Bhavani Gokha, , Maharashtra, , 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
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).
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 |
|---|---|---|---|
| 11/4/2010 | 66YAR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/4/2010 | 66YAR99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/4/2010 | 53YH99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 197COSM COLOR | Philadelphia District Office (PHI-DO) |
| 11/4/2010 | 53YH99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 197COSM COLOR | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Bharat Enterprises's FDA import refusal history?
Bharat Enterprises (FEI: 3008510717) has 4 FDA import refusal record(s) in our database, spanning from 11/4/2010 to 11/4/2010.
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. Bharat Enterprises's FEI number is 3008510717.
What types of violations has Bharat Enterprises received?
Bharat Enterprises has been cited for 2 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 Bharat Enterprises come from?
All FDA import refusal data for Bharat Enterprises 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.