Pro Eye Protection World P Ltd
⚠️ High Risk
FEI: 3007725874 • Chandigarh, Chandigarh • INDIA
FEI Number
3007725874
Location
Chandigarh, Chandigarh
Country
INDIAAddress
51 - 52 Sco, Madhya Marg, Chandigarh, Chandigarh, 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 |
|---|---|---|---|
| 9/2/2009 | 55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2009 | 60LCA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2009 | 61MCA06CLONAZEPAM (ANTI-CONVULSANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2009 | 55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2009 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/2/2009 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Pro Eye Protection World P Ltd's FDA import refusal history?
Pro Eye Protection World P Ltd (FEI: 3007725874) has 6 FDA import refusal record(s) in our database, spanning from 9/2/2009 to 9/2/2009.
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. Pro Eye Protection World P Ltd's FEI number is 3007725874.
What types of violations has Pro Eye Protection World P Ltd received?
Pro Eye Protection World P 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 Pro Eye Protection World P Ltd come from?
All FDA import refusal data for Pro Eye Protection World P 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.