Generics India
⚠️ High Risk
FEI: 3003848229 • Mumbai • 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 |
|---|---|---|---|
| 3/23/2017 | 60SCA23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61XCA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62GCA12CINTAZONE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 63BCA01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61XCA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62GCA12CINTAZONE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62GCA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61ACA06CHLOROQUINE PHOSPHATE (ANTI-AMEBIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 63BCA01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61PCA07GLIBORNURIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60LCA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 56ECA20DOXYCYCLINE (TETRACYCLINES) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61GDA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 62GCA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61ACA06CHLOROQUINE PHOSPHATE (ANTI-AMEBIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 63BCA02ALBUTEROL SULFATE (BRONCHODILATOR) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 61GDA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 60LCA01ACETAMINOPHEN (ANALGESIC) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 61ACA06CHLOROQUINE PHOSPHATE (ANTI-AMEBIC) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 61GDA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | New Orleans District Office (NOL-DO) | |
| 3/21/2017 | 61XCA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 62GCA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 61GDA57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 61HCA99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 61ACA06CHLOROQUINE PHOSPHATE (ANTI-AMEBIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 62CCA38METHYLDOPA (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2017 | 61ACA06CHLOROQUINE PHOSPHATE (ANTI-AMEBIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/24/2007 | 60LCA05ASPIRIN (ANALGESIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Generics India's FDA import refusal history?
Generics India (FEI: 3003848229) has 34 FDA import refusal record(s) in our database, spanning from 4/24/2007 to 3/23/2017.
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. Generics India's FEI number is 3003848229.
What types of violations has Generics India received?
Generics India 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 Generics India come from?
All FDA import refusal data for Generics India 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.