Antibioticos de Mexico S.A. de C.V.
⚠️ High Risk
FEI: 3003603933 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3003603933
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Las Flores No. 56, Pueblo Los Reyes, Coyoacan, Ciudad De Mexico, Ciudad de Mexico, 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
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).
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 |
|---|---|---|---|
| 11/14/2025 | 56BCE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 10/28/2025 | 56BCE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/23/2025 | 65ADA04MEMANTINE HCI | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/31/2024 | 56BDH03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2023 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2019 | 60RAC18ORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2015 | 56BCE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/16/2008 | 56CIY72CEFUROXIME SODIUM (CEPHALOSPORINS) | Cincinnati District Office (CIN-DO) | |
| 5/22/2007 | 56BAK10BENZYLPENICILLOYL-POLYLYSINE (PENICILLIN, SYNTHETICALLY PRODUCED) | Cincinnati District Office (CIN-DO) | |
| 5/21/2007 | 56BDK10BENZYLPENICILLOYL-POLYLYSINE (PENICILLIN, SYNTHETICALLY PRODUCED) | Cincinnati District Office (CIN-DO) | |
| 4/2/2007 | 56BCK52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Antibioticos de Mexico S.A. de C.V.'s FDA import refusal history?
Antibioticos de Mexico S.A. de C.V. (FEI: 3003603933) has 12 FDA import refusal record(s) in our database, spanning from 4/2/2007 to 11/14/2025.
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. Antibioticos de Mexico S.A. de C.V.'s FEI number is 3003603933.
What types of violations has Antibioticos de Mexico S.A. de C.V. received?
Antibioticos de Mexico S.A. de C.V. has been cited for 3 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 Antibioticos de Mexico S.A. de C.V. come from?
All FDA import refusal data for Antibioticos 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.