Scherin Plug
⚠️ Moderate Risk
FEI: 3005071969 • Antiguo Cuscatlan, La Libertad • EL SALVADOR
FEI Number
3005071969
Location
Antiguo Cuscatlan, La Libertad
Country
EL SALVADORAddress
Blvd Edif Bayer Ciudad Merliot, , Antiguo Cuscatlan, La Libertad, El Salvador
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 Scherin Plug's FDA import refusal history?
Scherin Plug (FEI: 3005071969) has 1 FDA import refusal record(s) in our database, spanning from 4/28/2005 to 4/28/2005.
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. Scherin Plug's FEI number is 3005071969.
What types of violations has Scherin Plug received?
Scherin Plug 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 Scherin Plug come from?
All FDA import refusal data for Scherin Plug 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.