Bio-Tech Vision Care Pvt
⚠️ Moderate Risk
FEI: 3005058978 • Gujarat • INDIA
FEI Number
3005058978
Location
Gujarat
Country
INDIAAddress
Plot #555,556,557khatraj-Vadsar Road, , Gujarat, , 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
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
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 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/8/2009 | 86HQLLENS, INTRAOCULAR | Cincinnati District Office (CIN-DO) | |
| 6/26/2007 | 86HQLLENS, INTRAOCULAR | 2380NO PMA/PDP | New York District Office (NYK-DO) |
| 4/23/2007 | 86HQLLENS, INTRAOCULAR | 237NO PMA | Los Angeles District Office (LOS-DO) |
| 3/20/2007 | 86HQLLENS, INTRAOCULAR | Los Angeles District Office (LOS-DO) | |
| 12/14/2006 | 86HQCUNIT, PHACOFRAGMENTATION | Los Angeles District Office (LOS-DO) | |
| 12/7/2006 | 86HQLLENS, INTRAOCULAR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Bio-Tech Vision Care Pvt's FDA import refusal history?
Bio-Tech Vision Care Pvt (FEI: 3005058978) has 6 FDA import refusal record(s) in our database, spanning from 12/7/2006 to 9/8/2009.
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. Bio-Tech Vision Care Pvt's FEI number is 3005058978.
What types of violations has Bio-Tech Vision Care Pvt received?
Bio-Tech Vision Care Pvt has been cited for 5 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 Vision Care Pvt come from?
All FDA import refusal data for Bio-Tech Vision Care Pvt 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.