Alpha-Pharma Heathcare
⚠️ Moderate Risk
FEI: 3008769367 • Mumbai, Maharashtra • INDIA
FEI Number
3008769367
Location
Mumbai, Maharashtra
Country
INDIAAddress
Sagar Tech Plaza, A#317 Andheri Kurla Road, 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 |
|---|---|---|---|
| 3/3/2011 | 63BCY35CLENBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/5/2011 | 65PCB02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2009 | 66JCA02LIOTHYRONINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/9/2008 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Alpha-Pharma Heathcare's FDA import refusal history?
Alpha-Pharma Heathcare (FEI: 3008769367) has 4 FDA import refusal record(s) in our database, spanning from 5/9/2008 to 3/3/2011.
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. Alpha-Pharma Heathcare's FEI number is 3008769367.
What types of violations has Alpha-Pharma Heathcare received?
Alpha-Pharma Heathcare 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 Alpha-Pharma Heathcare come from?
All FDA import refusal data for Alpha-Pharma Heathcare 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.