Chartwell Pharmaceuticals Amityville, LLC
⚠️ Moderate Risk
FEI: 2433247 • Amityville, NY • UNITED STATES
FEI Number
2433247
Location
Amityville, NY
Country
UNITED STATESAddress
369 Bayview Ave, , Amityville, NY, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
Frequently Asked Questions
What is Chartwell Pharmaceuticals Amityville, LLC's FDA import refusal history?
Chartwell Pharmaceuticals Amityville, LLC (FEI: 2433247) has 3 FDA import refusal record(s) in our database, spanning from 10/4/2006 to 3/11/2011.
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. Chartwell Pharmaceuticals Amityville, LLC's FEI number is 2433247.
What types of violations has Chartwell Pharmaceuticals Amityville, LLC received?
Chartwell Pharmaceuticals Amityville, LLC 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 Chartwell Pharmaceuticals Amityville, LLC come from?
All FDA import refusal data for Chartwell Pharmaceuticals Amityville, LLC 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.