Baxter Pharmaceuticals India Pvt Ltd
⚠️ Moderate Risk
FEI: 3004610460 • Ahmedabad, Gujarat • INDIA
FEI Number
3004610460
Location
Ahmedabad, Gujarat
Country
INDIAAddress
Village Vasana Chacharwadi, Taluka Sanand, Ahmedabad, Gujarat, 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).
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 |
|---|---|---|---|
| 11/19/2010 | 65RCN18SODIUM BICARBONATE (REPLENISHER) | New Orleans District Office (NOL-DO) | |
| 11/19/2010 | 65RCN18SODIUM BICARBONATE (REPLENISHER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/19/2010 | 65RCN18SODIUM BICARBONATE (REPLENISHER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Baxter Pharmaceuticals India Pvt Ltd's FDA import refusal history?
Baxter Pharmaceuticals India Pvt Ltd (FEI: 3004610460) has 3 FDA import refusal record(s) in our database, spanning from 11/19/2010 to 11/19/2010.
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. Baxter Pharmaceuticals India Pvt Ltd's FEI number is 3004610460.
What types of violations has Baxter Pharmaceuticals India Pvt Ltd received?
Baxter Pharmaceuticals India Pvt Ltd 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 Baxter Pharmaceuticals India Pvt Ltd come from?
All FDA import refusal data for Baxter Pharmaceuticals 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.