Swati Spentose Private Limited
⚠️ High Risk
FEI: 3009765202 • Vapi, Gujarat • INDIA
FEI Number
3009765202
Location
Vapi, Gujarat
Country
INDIAAddress
A - 1/2102 2103 Phase Iii, Gidc, Vapi, Gujarat, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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 |
|---|---|---|---|
| 12/5/2025 | 66QQY10PENTOSAN POLYSULFATE SODIUM (URICOSURIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/29/2016 | 60QCR07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2014 | 66QIY10PENTOSAN POLYSULFATE SODIUM (URICOSURIC) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Swati Spentose Private Limited's FDA import refusal history?
Swati Spentose Private Limited (FEI: 3009765202) has 3 FDA import refusal record(s) in our database, spanning from 7/21/2014 to 12/5/2025.
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. Swati Spentose Private Limited's FEI number is 3009765202.
What types of violations has Swati Spentose Private Limited received?
Swati Spentose Private Limited 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 Swati Spentose Private Limited come from?
All FDA import refusal data for Swati Spentose Private Limited 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.