Inga Pharmaceuticals
⚠️ High Risk
FEI: 1000488144 • Mumbai, Maharashtra • INDIA
FEI Number
1000488144
Location
Mumbai, Maharashtra
Country
INDIAAddress
Inga House, Mahakali Road, Andheri East, 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 |
|---|---|---|---|
| 5/23/2025 | 54YDY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/5/2020 | 56BYC03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2016 | 66FDY05COLCHICINE (SUPPRESSANT) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/6/2008 | 62CAS51RESERPINE (ANTI-HYPERTENSIVE) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 4/4/2008 | 61AIS09EMETINE HCL (ANTI-AMEBIC) | New Orleans District Office (NOL-DO) | |
| 12/20/2002 | 63IDS01PODOPHYLLUM RESIN (CAUSTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Inga Pharmaceuticals's FDA import refusal history?
Inga Pharmaceuticals (FEI: 1000488144) has 6 FDA import refusal record(s) in our database, spanning from 12/20/2002 to 5/23/2025.
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. Inga Pharmaceuticals's FEI number is 1000488144.
What types of violations has Inga Pharmaceuticals received?
Inga Pharmaceuticals 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 Inga Pharmaceuticals come from?
All FDA import refusal data for Inga Pharmaceuticals 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.