Franco-Indian Laboratories
⚠️ High Risk
FEI: 3002807008 • Mumbai, Maharashtra • INDIA
FEI Number
3002807008
Location
Mumbai, Maharashtra
Country
INDIAAddress
20 Dr. E. Moses Road, , 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/13/2025 | 61WDY04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/11/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 61PDY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/23/2024 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2024 | 61PDA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2024 | 61XDA07CHLOROTHEN CITRATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 61PDY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/11/2022 | 61PCY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/21/2021 | 64NDY10FERRIC AMMONIUM CITRATE (HEMATINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2017 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/7/2016 | 61WDO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 4/28/2015 | 66YAA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 5/28/2013 | 61WDO04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 8/9/2012 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2007 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/22/2006 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Franco-Indian Laboratories's FDA import refusal history?
Franco-Indian Laboratories (FEI: 3002807008) has 16 FDA import refusal record(s) in our database, spanning from 8/22/2006 to 8/13/2025.
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. Franco-Indian Laboratories's FEI number is 3002807008.
What types of violations has Franco-Indian Laboratories received?
Franco-Indian Laboratories 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 Franco-Indian Laboratories come from?
All FDA import refusal data for Franco-Indian Laboratories 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.