Indo Gulf Trading Company
⚠️ Moderate Risk
FEI: 3004111937 • Mumbai, Maharashtra • INDIA
FEI Number
3004111937
Location
Mumbai, Maharashtra
Country
INDIAAddress
51 / 57 Dontad Street, , Mumbai, 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
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).
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).
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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/8/2008 | 68YYY02HORSES ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 10/25/2005 | 63BCS27LEVALBUTEROL HCL (BRONCHODILATOR) | Seattle District Office (SEA-DO) | |
| 2/25/2004 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/20/2003 | 65PDB02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Indo Gulf Trading Company's FDA import refusal history?
Indo Gulf Trading Company (FEI: 3004111937) has 4 FDA import refusal record(s) in our database, spanning from 10/20/2003 to 4/8/2008.
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. Indo Gulf Trading Company's FEI number is 3004111937.
What types of violations has Indo Gulf Trading Company received?
Indo Gulf Trading Company 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 Indo Gulf Trading Company come from?
All FDA import refusal data for Indo Gulf Trading Company 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.