Alconon Laboratorios, S.A. De C.V.
✅ Low Risk
FEI: 3001611875 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3001611875
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Jose Maria Rico No. 418, Col. Del Valle Sur, Benito Juarez, Ciudad De Mexico, Ciudad de 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
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).
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 Alconon Laboratorios, S.A. De C.V.'s FDA import refusal history?
Alconon Laboratorios, S.A. De C.V. (FEI: 3001611875) has 1 FDA import refusal record(s) in our database, spanning from 12/12/2011 to 12/12/2011.
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. Alconon Laboratorios, S.A. De C.V.'s FEI number is 3001611875.
What types of violations has Alconon Laboratorios, S.A. De C.V. received?
Alconon Laboratorios, 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 Alconon Laboratorios, S.A. De C.V. come from?
All FDA import refusal data for Alconon Laboratorios, 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.