Hahnemann Laboratories, Inc., dba Alpine Pharmaceuticals
⚠️ High Risk
FEI: 3001239031 • San Rafael, CA • UNITED STATES
FEI Number
3001239031
Location
San Rafael, CA
Country
UNITED STATESAddress
1940 4th St, , San Rafael, CA, United States
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
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
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
Frequently Asked Questions
What is Hahnemann Laboratories, Inc., dba Alpine Pharmaceuticals's FDA import refusal history?
Hahnemann Laboratories, Inc., dba Alpine Pharmaceuticals (FEI: 3001239031) has 2 FDA import refusal record(s) in our database, spanning from 8/19/2009 to 9/5/2025.
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. Hahnemann Laboratories, Inc., dba Alpine Pharmaceuticals's FEI number is 3001239031.
What types of violations has Hahnemann Laboratories, Inc., dba Alpine Pharmaceuticals received?
Hahnemann Laboratories, Inc., dba Alpine Pharmaceuticals 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 Hahnemann Laboratories, Inc., dba Alpine Pharmaceuticals come from?
All FDA import refusal data for Hahnemann Laboratories, Inc., dba Alpine 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.