Gelnova Laboratories (India) Private Ltd.
⚠️ High Risk
FEI: 3010673418 • Navi Mumbai, Maharashtra • INDIA
FEI Number
3010673418
Location
Navi Mumbai, Maharashtra
Country
INDIAAddress
C-125 TTC Industrial Area, Mahape Road, 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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/6/2025 | 61WDY04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2021 | 62UCA01BENZONATATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/1/2012 | 54FMH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 72NEW VET DR | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Gelnova Laboratories (India) Private Ltd.'s FDA import refusal history?
Gelnova Laboratories (India) Private Ltd. (FEI: 3010673418) has 4 FDA import refusal record(s) in our database, spanning from 10/1/2012 to 10/6/2025.
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. Gelnova Laboratories (India) Private Ltd.'s FEI number is 3010673418.
What types of violations has Gelnova Laboratories (India) Private Ltd. received?
Gelnova Laboratories (India) Private 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 Gelnova Laboratories (India) Private Ltd. come from?
All FDA import refusal data for Gelnova Laboratories (India) Private 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.