Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
⚠️ Moderate Risk
FEI: 1039144 • Huntsville, AL • UNITED STATES
FEI Number
1039144
Location
Huntsville, AL
Country
UNITED STATESAddress
130 Vintage Dr Ne, , Huntsville, AL, United States
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
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals's FDA import refusal history?
Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals (FEI: 1039144) has 2 FDA import refusal record(s) in our database, spanning from 4/6/2012 to 11/20/2012.
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. Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals's FEI number is 1039144.
What types of violations has Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals received?
Vintage Pharmaceuticals LLC dba Qualitest 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 Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals come from?
All FDA import refusal data for Vintage Pharmaceuticals LLC dba Qualitest 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.