APPASAMY OCULAR DEVICES LTD
⚠️ Moderate Risk
FEI: 3027288320 • Katha, Himachal Pradesh • INDIA
FEI Number
3027288320
Location
Katha, Himachal Pradesh
Country
INDIAAddress
Plot No 74 - D, Distt Solan, Katha, Himachal Pradesh, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
Frequently Asked Questions
What is APPASAMY OCULAR DEVICES LTD's FDA import refusal history?
APPASAMY OCULAR DEVICES LTD (FEI: 3027288320) has 1 FDA import refusal record(s) in our database, spanning from 6/7/2024 to 6/7/2024.
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. APPASAMY OCULAR DEVICES LTD's FEI number is 3027288320.
What types of violations has APPASAMY OCULAR DEVICES LTD received?
APPASAMY OCULAR DEVICES 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 APPASAMY OCULAR DEVICES LTD come from?
All FDA import refusal data for APPASAMY OCULAR DEVICES 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.