Aurolab Trust DBA Aurolab
⚠️ Moderate Risk
FEI: 3002957101 • Veerapanjan Madurai, Tamil Nadu • INDIA
FEI Number
3002957101
Location
Veerapanjan Madurai, Tamil Nadu
Country
INDIAAddress
1 Sivagangai Main Road, , Veerapanjan Madurai, Tamil Nadu, 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).
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.
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/7/2023 | 63XIY29INDOCYANINE GREEN (DIAGNOSTIC AID) (DRUGS) | Division of Southeast Imports (DSEI) | |
| 10/31/2019 | 56YAY99ANTIBIOTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/7/2007 | 79GARSUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 3/8/2007 | 86HQLLENS, INTRAOCULAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 3/8/2007 | 86NCEINJECTOR, CAPSULAR TENSION RING | New Orleans District Office (NOL-DO) | |
| 3/8/2007 | 88LGYTRYPAN BLUE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/8/2007 | 63NDK21PILOCARPINE HCL (CHOLINERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/8/2007 | 60CDK54BRIMONIDINE TARTRATE (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/8/2007 | 60XDK23TIMOLOL MALEATE (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Aurolab Trust DBA Aurolab's FDA import refusal history?
Aurolab Trust DBA Aurolab (FEI: 3002957101) has 9 FDA import refusal record(s) in our database, spanning from 3/8/2007 to 4/7/2023.
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 Trust DBA Aurolab's FEI number is 3002957101.
What types of violations has Aurolab Trust DBA Aurolab received?
Aurolab Trust DBA Aurolab has been cited for 6 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 Trust DBA Aurolab come from?
All FDA import refusal data for Aurolab Trust DBA Aurolab 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.