Industrias Bernal Canton S.A. de C.V.
⚠️ Moderate Risk
FEI: 3016757963 • Cuernavaca, Morelos • MEXICO
FEI Number
3016757963
Location
Cuernavaca, Morelos
Country
MEXICOAddress
Calle Ejido No 161, Fracc. Satelite, Cuernavaca, Cuernavaca, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/26/2021 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Industrias Bernal Canton S.A. de C.V.'s FDA import refusal history?
Industrias Bernal Canton S.A. de C.V. (FEI: 3016757963) has 1 FDA import refusal record(s) in our database, spanning from 3/26/2021 to 3/26/2021.
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. Industrias Bernal Canton S.A. de C.V.'s FEI number is 3016757963.
What types of violations has Industrias Bernal Canton S.A. de C.V. received?
Industrias Bernal Canton 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 Industrias Bernal Canton S.A. de C.V. come from?
All FDA import refusal data for Industrias Bernal Canton 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.