Indiawell Enterprises
⚠️ Moderate Risk
FEI: 3004548530 • New Delhi, Delhi • INDIA
FEI Number
3004548530
Location
New Delhi, Delhi
Country
INDIAAddress
2976 Kucha Mai Dasbazar Sitaram, , 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
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).
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.
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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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 |
|---|---|---|---|
| 7/10/2004 | 60LBJ99ANALGESIC, N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/10/2004 | 60LBJ99ANALGESIC, N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/2/2004 | 66VBR99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/2/2004 | 66VBB99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Indiawell Enterprises's FDA import refusal history?
Indiawell Enterprises (FEI: 3004548530) has 4 FDA import refusal record(s) in our database, spanning from 7/2/2004 to 7/10/2004.
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. Indiawell Enterprises's FEI number is 3004548530.
What types of violations has Indiawell Enterprises received?
Indiawell Enterprises has been cited for 5 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 Indiawell Enterprises come from?
All FDA import refusal data for Indiawell 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.