Schwabe Mexico S.A. de C.V.
⚠️ Moderate Risk
FEI: 3004120076 • Xochitepec, Morelos • MEXICO
FEI Number
3004120076
Location
Xochitepec, Morelos
Country
MEXICOAddress
Aguacate 4, Col. El Estudiante, Xochitepec, Morelos, Mexico
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
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).
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).
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: 3004120076) has 3 FDA import refusal record(s) in our database, spanning from 12/10/2019 to 11/22/2023.
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 3004120076.
What types of violations has Schwabe Mexico S.A. de C.V. received?
Schwabe Mexico S.A. de C.V. 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 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.