SALUD CARE INDIA PVT LTD
⚠️ High Risk
FEI: 3031431611 • Kolkata, West Bengal • INDIA
FEI Number
3031431611
Location
Kolkata, West Bengal
Country
INDIAAddress
172b Kaikhali Main Rd, , Kolkata, West Bengal, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/24/2025 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SALUD CARE INDIA PVT LTD's FDA import refusal history?
SALUD CARE INDIA PVT LTD (FEI: 3031431611) has 1 FDA import refusal record(s) in our database, spanning from 4/24/2025 to 4/24/2025.
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. SALUD CARE INDIA PVT LTD's FEI number is 3031431611.
What types of violations has SALUD CARE INDIA PVT LTD received?
SALUD CARE INDIA PVT LTD has been cited for 1 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 SALUD CARE INDIA PVT LTD come from?
All FDA import refusal data for SALUD CARE INDIA PVT LTD 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.