Antisepticos de Mexico, S.A. de C.V.
⚠️ High Risk
FEI: 3016821067 • La Ermita, Guanajuato • MEXICO
FEI Number
3016821067
Location
La Ermita, Guanajuato
Country
MEXICOAddress
Boulevard Clio No. 1029, Col. La Ermita 1ra Secc, Leon, La Ermita, Guanajuato, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/17/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/17/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/17/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/17/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/17/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/17/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/17/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/17/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/17/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/17/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 5/17/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 12/30/2020 | 62HAY99ANTI-MICROBIAL N.E.C. | 118NOT LISTED | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Antisepticos de Mexico, S.A. de C.V.'s FDA import refusal history?
Antisepticos de Mexico, S.A. de C.V. (FEI: 3016821067) has 12 FDA import refusal record(s) in our database, spanning from 12/30/2020 to 5/17/2021.
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. Antisepticos de Mexico, S.A. de C.V.'s FEI number is 3016821067.
What types of violations has Antisepticos de Mexico, S.A. de C.V. received?
Antisepticos de 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 Antisepticos de Mexico, S.A. de C.V. come from?
All FDA import refusal data for Antisepticos de 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.