Sunrider Manufacturing L.P.
⚠️ Moderate Risk
FEI: 1000125398 • Midlothian, TX • UNITED STATES
FEI Number
1000125398
Location
Midlothian, TX
Country
UNITED STATESAddress
3201 Challenger Dr, , Midlothian, TX, 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
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.
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 Sunrider Manufacturing L.P.'s FDA import refusal history?
Sunrider Manufacturing L.P. (FEI: 1000125398) has 2 FDA import refusal record(s) in our database, spanning from 9/9/2015 to 9/9/2015.
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. Sunrider Manufacturing L.P.'s FEI number is 1000125398.
What types of violations has Sunrider Manufacturing L.P. received?
Sunrider Manufacturing L.P. 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 Sunrider Manufacturing L.P. come from?
All FDA import refusal data for Sunrider Manufacturing L.P. 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.