Boehringer Ingelheim India Pvt Ltd
⚠️ Moderate Risk
FEI: 3009810337 • Mumbai, Maharashtra • INDIA
FEI Number
3009810337
Location
Mumbai, Maharashtra
Country
INDIAAddress
11th Floor, L Hallmark Business, Mumbai, Maharashtra, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/26/2021 | 61PCA99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/24/2021 | 61PCA99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2021 | 61PCE99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/20/2020 | 61PDB66LINAGLIPTIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Boehringer Ingelheim India Pvt Ltd's FDA import refusal history?
Boehringer Ingelheim India Pvt Ltd (FEI: 3009810337) has 4 FDA import refusal record(s) in our database, spanning from 11/20/2020 to 7/26/2021.
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. Boehringer Ingelheim India Pvt Ltd's FEI number is 3009810337.
What types of violations has Boehringer Ingelheim India Pvt Ltd received?
Boehringer Ingelheim India Pvt Ltd has been cited for 1 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 Boehringer Ingelheim India Pvt Ltd come from?
All FDA import refusal data for Boehringer Ingelheim India Pvt 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.