Gopaldas Visram & Co., Ltd.
⚠️ High Risk
FEI: 3009565091 • Navi Mumbai, Maharashtra • INDIA
FEI Number
3009565091
Location
Navi Mumbai, Maharashtra
Country
INDIAAddress
Ttc Industrial Area, A327 Midc Mahape, Navi Mumbai, Maharashtra, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/3/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/29/2021 | 54AGZ90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/22/2021 | 61XBL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 7/9/2019 | 61WBJ18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Northeast Imports (DNEI) | |
| 10/25/2018 | 63ACR99BONE CALCIUM REGULATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Gopaldas Visram & Co., Ltd.'s FDA import refusal history?
Gopaldas Visram & Co., Ltd. (FEI: 3009565091) has 5 FDA import refusal record(s) in our database, spanning from 10/25/2018 to 10/3/2024.
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. Gopaldas Visram & Co., Ltd.'s FEI number is 3009565091.
What types of violations has Gopaldas Visram & Co., Ltd. received?
Gopaldas Visram & Co., Ltd. has been cited for 2 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 Gopaldas Visram & Co., Ltd. come from?
All FDA import refusal data for Gopaldas Visram & Co., 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.