American Ophthalmic Laboratories, India Pvt Ltd
✅ Low Risk
FEI: 3003981996 • Colmbatore 641028 India • INDIA
FEI Number
3003981996
Location
Colmbatore 641028 India
Country
INDIAAddress
No. 432 G.V. Residency Sowripolayam, , Colmbatore 641028 India, , India
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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 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
Frequently Asked Questions
What is American Ophthalmic Laboratories, India Pvt Ltd's FDA import refusal history?
American Ophthalmic Laboratories, India Pvt Ltd (FEI: 3003981996) has 1 FDA import refusal record(s) in our database, spanning from 11/24/2004 to 11/24/2004.
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. American Ophthalmic Laboratories, India Pvt Ltd's FEI number is 3003981996.
What types of violations has American Ophthalmic Laboratories, India Pvt Ltd received?
American Ophthalmic Laboratories, India Pvt Ltd 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 American Ophthalmic Laboratories, India Pvt Ltd come from?
All FDA import refusal data for American Ophthalmic Laboratories, India 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.