M/S Tarun Enterprises
⚠️ Moderate Risk
FEI: 3003951061 • Allahabad, Uttar Pradesh • INDIA
FEI Number
3003951061
Location
Allahabad, Uttar Pradesh
Country
INDIAAddress
8/8 Strachy Road, , Allahabad, Uttar 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).
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).
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.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/20/2022 | 86QMMHYDROPHILIC RE-COATING SOLUTION | Division of Southeast Imports (DSEI) | |
| 9/26/2018 | 63XCY12FLUORESCEIN SODIUM (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2013 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | New Orleans District Office (NOL-DO) | |
| 11/19/2010 | 63XCK12FLUORESCEIN SODIUM (DIAGNOSTIC AID) (DRUGS) | Southwest Import District Office (SWI-DO) | |
| 3/10/2005 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | New York District Office (NYK-DO) | |
| 4/15/2004 | 86KYCSTRIP, FLUORESCEIN | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is M/S Tarun Enterprises's FDA import refusal history?
M/S Tarun Enterprises (FEI: 3003951061) has 6 FDA import refusal record(s) in our database, spanning from 4/15/2004 to 4/20/2022.
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. M/S Tarun Enterprises's FEI number is 3003951061.
What types of violations has M/S Tarun Enterprises received?
M/S Tarun Enterprises 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 M/S Tarun Enterprises come from?
All FDA import refusal data for M/S Tarun Enterprises 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.