Schwabe Mexico S.A. De C.V.
✅ Low Risk
FEI: 3008291663 • Mexico • MEXICO
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Schwabe Mexico S.A. De C.V.'s FDA import refusal history?
Schwabe Mexico S.A. De C.V. (FEI: 3008291663) has 2 FDA import refusal record(s) in our database, spanning from 5/10/2013 to 5/10/2013.
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. Schwabe Mexico S.A. De C.V.'s FEI number is 3008291663.
What types of violations has Schwabe Mexico S.A. De C.V. received?
Schwabe Mexico S.A. De C.V. has been cited for 1 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 Schwabe Mexico S.A. De C.V. come from?
All FDA import refusal data for Schwabe Mexico S.A. De C.V. 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.