Quimica y Farmacia S.A. de C.V.
⚠️ High Risk
FEI: 3007721565 • Ramos Arizpe, Coahuila • MEXICO
FEI Number
3007721565
Location
Ramos Arizpe, Coahuila
Country
MEXICOAddress
Blvd. Industrias Automotriz #3045, Fracc. Ii, Ramos Arizpe Centro, Ramos Arizpe, Coahuila, 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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/12/2025 | 60LCA01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 12/12/2025 | 60LCA01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 9/24/2025 | 66FCY05COLCHICINE (SUPPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/5/2025 | 60NCY10OXYMETHOLONE (ANDROGEN) | Division of Southeast Imports (DSEI) | |
| 2/27/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2023 | 60LCB01ACETAMINOPHEN (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 9/19/2022 | 56BYY05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/6/2022 | 60LBA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2021 | 60LDA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2021 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Division of Southeast Imports (DSEI) | |
| 1/6/2021 | 60LDB01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/18/2019 | 60SCL14MAGNESIUM HYDROXIDE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2019 | 66FDY05COLCHICINE (SUPPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/30/2019 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2019 | 62KCA10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/14/2018 | 62VCY19ACYCLOVIR SODIUM (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 60QDA07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 60QDY07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/8/2017 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/9/2017 | 62VCJ18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/9/2017 | 62GCA86ALLOPURINOL SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/23/2017 | 64LCJ06BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/24/2017 | 62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/9/2016 | 61XCA08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2016 | 66SCA03BETAHISTINE HCL (VASODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/16/2016 | 56KCK99MISCELLANEOUS ANTIBIOTICS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 10/7/2016 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/3/2016 | 62GDB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/3/2016 | 62GDJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2016 | 62GAB94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/27/2012 | 60LAS01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 7/3/2007 | 62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/17/2007 | 61HDA03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/18/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/4/2002 | 60SBL03ALUMINA/MAGNESIA (ANTACID) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Quimica y Farmacia S.A. de C.V.'s FDA import refusal history?
Quimica y Farmacia S.A. de C.V. (FEI: 3007721565) has 36 FDA import refusal record(s) in our database, spanning from 11/4/2002 to 12/12/2025.
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. Quimica y Farmacia S.A. de C.V.'s FEI number is 3007721565.
What types of violations has Quimica y Farmacia S.A. de C.V. received?
Quimica y Farmacia S.A. de C.V. 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 Quimica y Farmacia S.A. de C.V. come from?
All FDA import refusal data for Quimica y Farmacia 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.