Paramount Surgimed Limited
⚠️ Moderate Risk
FEI: 1000388472 • Rajasthan • INDIA
FEI Number
1000388472
Location
Rajasthan
Country
INDIAAddress
A-106 Ricco Industrial Area PH-1, Bhiwadi, Rajasthan, , 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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/18/2002 | 79GESBLADE, SCALPEL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 7/24/2002 | 79GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 7/24/2002 | 79GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | 290DE IMP GMP | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Paramount Surgimed Limited's FDA import refusal history?
Paramount Surgimed Limited (FEI: 1000388472) has 3 FDA import refusal record(s) in our database, spanning from 7/24/2002 to 9/18/2002.
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. Paramount Surgimed Limited's FEI number is 1000388472.
What types of violations has Paramount Surgimed Limited received?
Paramount Surgimed Limited 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 Paramount Surgimed Limited come from?
All FDA import refusal data for Paramount Surgimed 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.