Aurolab Aravind Eye Hospital
⚠️ Moderate Risk
FEI: 3004932646 • Madurai • 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/18/2007 | 63XNY29INDOCYANINE GREEN (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/4/2007 | 61IIJ99ANTI-BACTERIAL ENZYME, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2006 | 61IIJ99ANTI-BACTERIAL ENZYME, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/29/2006 | 61IIJ99ANTI-BACTERIAL ENZYME, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2006 | 61IIJ99ANTI-BACTERIAL ENZYME, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/7/2006 | 61IIJ99ANTI-BACTERIAL ENZYME, N.E.C. | 472NO ENGLISH | Division of Southeast Imports (DSEI) |
| 2/3/2006 | 61IIJ99ANTI-BACTERIAL ENZYME, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/19/2005 | 61IIJ99ANTI-BACTERIAL ENZYME, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Aurolab Aravind Eye Hospital's FDA import refusal history?
Aurolab Aravind Eye Hospital (FEI: 3004932646) has 8 FDA import refusal record(s) in our database, spanning from 7/19/2005 to 9/18/2007.
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. Aurolab Aravind Eye Hospital's FEI number is 3004932646.
What types of violations has Aurolab Aravind Eye Hospital received?
Aurolab Aravind Eye Hospital 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 Aurolab Aravind Eye Hospital come from?
All FDA import refusal data for Aurolab Aravind Eye Hospital 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.