Xymogen Manufacturing, LLC
✅ Low Risk
FEI: 3004315824 • Orlando, FL • UNITED STATES
FEI Number
3004315824
Location
Orlando, FL
Country
UNITED STATESAddress
6900 Kingspointe Pkwy, , Orlando, FL, United States
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
Frequently Asked Questions
What is Xymogen Manufacturing, LLC's FDA import refusal history?
Xymogen Manufacturing, LLC (FEI: 3004315824) has 1 FDA import refusal record(s) in our database, spanning from 3/15/2016 to 3/15/2016.
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. Xymogen Manufacturing, LLC's FEI number is 3004315824.
What types of violations has Xymogen Manufacturing, LLC received?
Xymogen Manufacturing, LLC 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 Xymogen Manufacturing, LLC come from?
All FDA import refusal data for Xymogen Manufacturing, 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.