BLUE CROSS LABORATORIES PVT LTD
⚠️ High Risk
FEI: 3013381637 • VERNA GOA • INDIA
FEI Number
3013381637
Location
VERNA GOA
Country
INDIAAddress
L 17 VERNA INDUSTRIAL E, , VERNA GOA, , 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 |
|---|---|---|---|
| 10/6/2025 | 61KDA16DICYCLOMINE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/6/2025 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/14/2025 | 61KDB16DICYCLOMINE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/3/2024 | 62GDY48MEFENAMIC ACID (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/16/2024 | 62GDY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/16/2024 | 61KDY16DICYCLOMINE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2024 | 63ODA07SUMATRIPTAN SUCCINATE (ANTIMIGRAINE AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2023 | 62GDE48MEFENAMIC ACID (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BLUE CROSS LABORATORIES PVT LTD's FDA import refusal history?
BLUE CROSS LABORATORIES PVT LTD (FEI: 3013381637) has 8 FDA import refusal record(s) in our database, spanning from 1/31/2023 to 10/6/2025.
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. BLUE CROSS LABORATORIES PVT LTD's FEI number is 3013381637.
What types of violations has BLUE CROSS LABORATORIES PVT LTD received?
BLUE CROSS LABORATORIES 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 BLUE CROSS LABORATORIES PVT LTD come from?
All FDA import refusal data for BLUE CROSS LABORATORIES 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.