Indoco Remedies Limited
⚠️ High Risk
FEI: 3004646335 • Mumbai, Maharashtra • INDIA
FEI Number
3004646335
Location
Mumbai, Maharashtra
Country
INDIAAddress
18 A Mahakali Caves 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2004 | 65ACL99MEMORY ADJUVANT, N.E.C. | New York District Office (NYK-DO) | |
| 9/29/2004 | 62UCL99ANTI-TUSSIVE/COLD N.E.C. | New York District Office (NYK-DO) | |
| 9/29/2004 | 60LAL01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 9/29/2004 | 61KCP16DICYCLOMINE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2004 | 62LCL40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2004 | 62KDL99ANTI-PERISTALTIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2004 | 60WCL01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2004 | 56DCK20GENTAMICIN (AMINOGLYCOSIDES) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2004 | 61FDK54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2004 | 62UDL99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2004 | 61XDL18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2004 | 61XCL45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2004 | 60QDJ99ANESTHETIC, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2004 | 60LDI99ANALGESIC, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2004 | 61WDJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2004 | 61WCJ04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/29/2004 | 62GCP18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Indoco Remedies Limited's FDA import refusal history?
Indoco Remedies Limited (FEI: 3004646335) has 17 FDA import refusal record(s) in our database, spanning from 9/29/2004 to 9/29/2004.
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. Indoco Remedies Limited's FEI number is 3004646335.
What types of violations has Indoco Remedies Limited received?
Indoco Remedies Limited 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 Indoco Remedies Limited come from?
All FDA import refusal data for Indoco Remedies 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.