Industria Farmaceutica Andromaco S.A. de C.V.
⚠️ High Risk
FEI: 3000223220 • Zona Industrial Parque Industrial Toluca 2000, Mexico • MEXICO
FEI Number
3000223220
Location
Zona Industrial Parque Industrial Toluca 2000, Mexico
Country
MEXICOAddress
Calle Eje 3 Norte No. 202 Parque Industrial Toluca 2000, , Zona Industrial Parque Industrial Toluca 2000, 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
FILTH
The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that the article contains potentially hazardous, or otherwise objectionable in light of intended use, microbial adulteration and therefore consists in part of a filthy substance
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).
INSANITARY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/28/2025 | 62WAY09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Southeast Imports (DSEI) | |
| 5/28/2025 | 62WAY09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Southeast Imports (DSEI) | |
| 5/28/2025 | 62WAY09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Southeast Imports (DSEI) | |
| 5/27/2025 | 62WAY09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Southeast Imports (DSEI) | |
| 9/6/2022 | 62WAO09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2020 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 11/13/2017 | 65LAJ13ZINC GELATIN (PROTECTANT) | Division of Southwest Imports (DSWI) | |
| 3/31/2017 | 61FCA42ISOCONAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/1/2016 | 66VBH99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2008 | 60LDM01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Industria Farmaceutica Andromaco S.A. de C.V.'s FDA import refusal history?
Industria Farmaceutica Andromaco S.A. de C.V. (FEI: 3000223220) has 10 FDA import refusal record(s) in our database, spanning from 3/13/2008 to 5/28/2025.
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. Industria Farmaceutica Andromaco S.A. de C.V.'s FEI number is 3000223220.
What types of violations has Industria Farmaceutica Andromaco S.A. de C.V. received?
Industria Farmaceutica Andromaco S.A. de C.V. has been cited for 8 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 Industria Farmaceutica Andromaco S.A. de C.V. come from?
All FDA import refusal data for Industria Farmaceutica Andromaco 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.