Grimann, S.A. de C.V.
🚨 Critical Risk
FEI: 3006076347 • Lerma, Edo Mexico • MEXICO
FEI Number
3006076347
Location
Lerma, Edo Mexico
Country
MEXICOAddress
Circuito Nemesio Diez Riega No. 11, Parque Industrial El Cerrillo Ii, Lerma, Edo Mexico, Mexico
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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 |
|---|---|---|---|
| 7/11/2025 | 54AEA18VITAMIN K (PHYTONADIONE) | Division of Southeast Imports (DSEI) | |
| 6/11/2025 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 66SCB49PENTOXIFYLLINE (VASODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/26/2025 | 56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/8/2025 | 62WDA11BISMUTH SUBGALLATE ASTRINGENT/ANTI-PERSPIRANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2024 | 64PDA99HEMOSTATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/16/2024 | 60LCE01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/24/2024 | 56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/13/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/20/2023 | 56DDA40NEOMYCIN (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/6/2023 | 62CDY99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/23/2023 | 60FDA01KAOLIN (ADSORBANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/29/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2023 | 64PCK99HEMOSTATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2023 | 56BDH05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/17/2022 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/17/2022 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2022 | 56BCK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2022 | 66YIA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2022 | 56BCA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/15/2022 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2022 | 65LCA16HYDROXYPROPYL CELLULOSE (PROTECTANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/8/2022 | 56BCK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2021 | 56BCH05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2020 | 56BYY05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/22/2020 | 56DDB49NEOMYCIN, N.E.C. (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 56BCA05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2019 | 56BCR03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/5/2019 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/18/2019 | 56BDK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/16/2019 | 65SDY99RUBEFACIENT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2019 | 62EDY99ANTI-HYPOTENSIVE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/4/2019 | 61FCA30DICLOXACILLIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/31/2019 | 60WCB01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/1/2019 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/7/2018 | 56BCC51PENICILLAMINE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/4/2018 | 65JCL31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/21/2018 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/14/2018 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/17/2018 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2017 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 9/28/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2017 | 60CCY99ADRENERGIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/8/2017 | 62GCC18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 56BDE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 61HCA43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2017 | 64NCK08IRON SORBITEX (HEMATINIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2017 | 61KCY54OXYPHENONIUM BROMIDE (ANTI-CHOLINERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/28/2017 | 56BDY05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2017 | 60WDL01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/22/2017 | 60WDL01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/10/2017 | 56BDY05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/8/2017 | 56BCE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/28/2016 | 61FDC30DICLOXACILLIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2016 | 56BCE19SODIUM DICLOXACILLIN MONOHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2016 | 56YCA99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/9/2016 | 61TCA07DIPHENIDOL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2016 | 62GAB94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/5/2016 | 65JCY31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/5/2016 | 61HAA43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | Florida District Office (FLA-DO) | |
| 4/1/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/1/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/16/2016 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/12/2013 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Grimann, S.A. de C.V.'s FDA import refusal history?
Grimann, S.A. de C.V. (FEI: 3006076347) has 66 FDA import refusal record(s) in our database, spanning from 3/12/2013 to 7/11/2025.
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. Grimann, S.A. de C.V.'s FEI number is 3006076347.
What types of violations has Grimann, S.A. de C.V. received?
Grimann, 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 Grimann, S.A. de C.V. come from?
All FDA import refusal data for Grimann, 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.