ANTIBIOTICOS DE MEXICO, S.A. DE
⚠️ High Risk
FEI: 3013852651 • Coyoacan, COL. • MEXICO
FEI Number
3013852651
Location
Coyoacan, COL.
Country
MEXICOAddress
Las Flores No 56, , Coyoacan, COL., 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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/14/2025 | 56BCE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 4/14/2025 | 56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2024 | 56DCY06AMIKACIN SULFATE (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2023 | 60RDY18ORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2022 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2022 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2022 | 60SCA13MAGNESIUM CARBONATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2022 | 56BCA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | Division of Southeast Imports (DSEI) | |
| 8/23/2022 | 62FCY53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ANTIBIOTICOS DE MEXICO, S.A. DE's FDA import refusal history?
ANTIBIOTICOS DE MEXICO, S.A. DE (FEI: 3013852651) has 9 FDA import refusal record(s) in our database, spanning from 8/23/2022 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's FEI number is 3013852651.
What types of violations has ANTIBIOTICOS DE MEXICO, S.A. DE received?
ANTIBIOTICOS DE MEXICO, S.A. DE 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 come from?
All FDA import refusal data for ANTIBIOTICOS DE MEXICO, S.A. DE 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.