Bio-Tech Opthalmics Pvt Ltd
⚠️ Moderate Risk
FEI: 3005812860 • Ahmedabadahmedabad • INDIA
FEI Number
3005812860
Location
Ahmedabadahmedabad
Country
INDIAAddress
Factory Plot - 555/56/57near Shubham, , Ahmedabadahmedabad, , 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Bio-Tech Opthalmics Pvt Ltd's FDA import refusal history?
Bio-Tech Opthalmics Pvt Ltd (FEI: 3005812860) has 1 FDA import refusal record(s) in our database, spanning from 7/24/2008 to 7/24/2008.
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. Bio-Tech Opthalmics Pvt Ltd's FEI number is 3005812860.
What types of violations has Bio-Tech Opthalmics Pvt Ltd received?
Bio-Tech Opthalmics Pvt Ltd has been cited for 3 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 Bio-Tech Opthalmics Pvt Ltd come from?
All FDA import refusal data for Bio-Tech Opthalmics 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.