Visions Enterprises Pvt Ltd
⚠️ High Risk
FEI: 3003680953 • Rajendranagar • INDIA
FEI Number
3003680953
Location
Rajendranagar
Country
INDIAAddress
198 Arunodaya Colony, Besides, , Rajendranagar, , India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/27/2003 | 62UBJ99ANTI-TUSSIVE/COLD N.E.C. | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 8/27/2003 | 62UBB99ANTI-TUSSIVE/COLD N.E.C. | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 5/17/2003 | 24HCE07PEPPER, SWEET, DRIED OR PASTE | Chicago District Office (CHI-DO) | |
| 5/17/2003 | 24HCE07PEPPER, SWEET, DRIED OR PASTE | Chicago District Office (CHI-DO) | |
| 5/17/2003 | 21SCE15MANGOSTEEN (SUBTROPICAL AND TROPICAL FRUIT) | Chicago District Office (CHI-DO) | |
| 5/17/2003 | 21SCE15MANGOSTEEN (SUBTROPICAL AND TROPICAL FRUIT) | Chicago District Office (CHI-DO) | |
| 5/17/2003 | 21SCE15MANGOSTEEN (SUBTROPICAL AND TROPICAL FRUIT) | Chicago District Office (CHI-DO) | |
| 5/17/2003 | 21SCE15MANGOSTEEN (SUBTROPICAL AND TROPICAL FRUIT) | Chicago District Office (CHI-DO) | |
| 2/5/2003 | 62MAO01CAMPHOR (ANTI-PRURITIC) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Visions Enterprises Pvt Ltd's FDA import refusal history?
Visions Enterprises Pvt Ltd (FEI: 3003680953) has 9 FDA import refusal record(s) in our database, spanning from 2/5/2003 to 8/27/2003.
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. Visions Enterprises Pvt Ltd's FEI number is 3003680953.
What types of violations has Visions Enterprises Pvt Ltd received?
Visions Enterprises Pvt Ltd has been cited for 4 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 Visions Enterprises Pvt Ltd come from?
All FDA import refusal data for Visions Enterprises 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.