Mepromax Lifesciences Pvt. Ltd.
⚠️ High Risk
FEI: 3006981432 • Selaqui, Uttarakhand • INDIA
FEI Number
3006981432
Location
Selaqui, Uttarakhand
Country
INDIAAddress
16 - Pharmacity, Uttarakhand, Selaqui, Uttarakhand, 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 |
|---|---|---|---|
| 10/9/2025 | 64LCY03BETAMETHASONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 11/22/2024 | 64LDY67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2024 | 64EDY02PANCREATIN (ENZYME) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2024 | 56JCJ31CLINDAMYCIN PHOSPHATE (LINCOMYCINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2023 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/14/2021 | 61WCA52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/17/2020 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/18/2019 | 62GDA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2016 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 6/23/2016 | 61XCA51LEVOCETIRIZINE DIHYDROCHLORIDE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/5/2009 | 61WDB52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mepromax Lifesciences Pvt. Ltd.'s FDA import refusal history?
Mepromax Lifesciences Pvt. Ltd. (FEI: 3006981432) has 11 FDA import refusal record(s) in our database, spanning from 6/5/2009 to 10/9/2025.
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. Mepromax Lifesciences Pvt. Ltd.'s FEI number is 3006981432.
What types of violations has Mepromax Lifesciences Pvt. Ltd. received?
Mepromax Lifesciences Pvt. Ltd. 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 Mepromax Lifesciences Pvt. Ltd. come from?
All FDA import refusal data for Mepromax Lifesciences 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.