Productos Farmaceuticos, SA de CV
⚠️ High Risk
FEI: 3012456220 • Rincon De Romos, Aguascalientes • MEXICO
FEI Number
3012456220
Location
Rincon De Romos, Aguascalientes
Country
MEXICOAddress
Carretera Pabellon De Hildalgo Km 4.2, , Rincon De Romos, Aguascalientes, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/28/2025 | 62VDA01AMANTADINE HCL (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2024 | 54AGY05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2024 | 60LDA99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/28/2024 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2024 | 62GCL94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2024 | 64LCK20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/31/2024 | 66FDA99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/15/2024 | 64LDB20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2024 | 61XCL51LEVOCETIRIZINE DIHYDROCHLORIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2024 | 60CCL99ADRENERGIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2024 | 63BCL25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2023 | 64LDL19DEXAMETHASONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 11/28/2023 | 62LCK52PERMETHRIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/5/2023 | 64LCA19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2022 | 64LCK19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2022 | 62LCK52PERMETHRIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | Division of Southeast Imports (DSEI) | |
| 7/8/2022 | 60QDY07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2021 | 62GDA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2021 | 54ADY05VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/14/2021 | 56IDB76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 64LCA19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2020 | 64HIA99EXPECTORANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 61XDY08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2020 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/16/2019 | 62VDY01AMANTADINE HCL (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2019 | 63HDY99CATHARTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/4/2019 | 65QCB99RELAXANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/7/2018 | 62GCC99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/12/2018 | 66FDK99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2017 | 66BLB43DEXMETHYLPHENIDATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/11/2017 | 62GDA50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/19/2017 | 62GDB99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2017 | 62GDA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/31/2017 | 61ECL99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/11/2017 | 66MCB83HYDROXYZINE HCL (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/4/2017 | 64LDJ28FLUOCINONIDE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/24/2016 | 56GDH99ANTIFUNGAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Productos Farmaceuticos, SA de CV's FDA import refusal history?
Productos Farmaceuticos, SA de CV (FEI: 3012456220) has 38 FDA import refusal record(s) in our database, spanning from 8/24/2016 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. Productos Farmaceuticos, SA de CV's FEI number is 3012456220.
What types of violations has Productos Farmaceuticos, SA de CV received?
Productos Farmaceuticos, SA de CV has been cited for 4 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 Productos Farmaceuticos, SA de CV come from?
All FDA import refusal data for Productos Farmaceuticos, SA de CV 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.