Optechnics Unlimited
⚠️ Moderate Risk
FEI: 3003888345 • Gurgaon, Haryana • INDIA
FEI Number
3003888345
Location
Gurgaon, Haryana
Country
INDIAAddress
A 26 Vijay Rattan Apartment, , Gurgaon, Haryana, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/5/2003 | 86HQLLENS, INTRAOCULAR | Cincinnati District Office (CIN-DO) | |
| 3/5/2003 | 86LYLACCESSORIES TO CONTACT LENS SOLUTION | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 3/5/2003 | 79GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 3/5/2003 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Optechnics Unlimited's FDA import refusal history?
Optechnics Unlimited (FEI: 3003888345) has 4 FDA import refusal record(s) in our database, spanning from 3/5/2003 to 3/5/2003.
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. Optechnics Unlimited's FEI number is 3003888345.
What types of violations has Optechnics Unlimited received?
Optechnics Unlimited 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 Optechnics Unlimited come from?
All FDA import refusal data for Optechnics Unlimited 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.