Bliss GVS Pharma Limited
⚠️ High Risk
FEI: 3008380269 • Palghar, Maharashtra • INDIA
FEI Number
3008380269
Location
Palghar, Maharashtra
Country
INDIAAddress
Plot No 11, Survey No 38,, Gut No. 312, Dewan Udyog Nagar; Aliyali Village, Palghar, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/4/2025 | 62GDA90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 9/24/2024 | 61WBJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Northeast Imports (DNEI) | |
| 8/22/2024 | 62LDY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/17/2024 | 61WDO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2024 | 60LDA85MESALAMINE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2024 | 62LDL46HALOFANTRINE HYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/25/2024 | 61WDY04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 1/23/2024 | 56GDL99ANTIFUNGAL N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/18/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/29/2022 | 61WDJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/25/2021 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/29/2019 | 62LDA99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/11/2018 | 60LCY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2017 | 61WBO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/3/2017 | 62LCA30MEFLOQUINE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/21/2016 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2016 | 62LDA99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/15/2016 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/13/2015 | 56GBJ99ANTIFUNGAL N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/21/2015 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/15/2010 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bliss GVS Pharma Limited's FDA import refusal history?
Bliss GVS Pharma Limited (FEI: 3008380269) has 21 FDA import refusal record(s) in our database, spanning from 11/15/2010 to 3/4/2025.
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. Bliss GVS Pharma Limited's FEI number is 3008380269.
What types of violations has Bliss GVS Pharma Limited received?
Bliss GVS Pharma Limited 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 Bliss GVS Pharma Limited come from?
All FDA import refusal data for Bliss GVS Pharma Limited 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.