LABORATORIOS GROSSMAN S.A
⚠️ High Risk
FEI: 3012845835 • Coyoacan • MEXICO
FEI Number
3012845835
Location
Coyoacan
Country
MEXICOAddress
Number Tlalpan 2021, , Coyoacan, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2026 | 54AFK99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/20/2026 | 66JCB02LIOTHYRONINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 54AGY11HYDROXOCOBALAMIN (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2024 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2024 | 54AGP11HYDROXOCOBALAMIN (VITAMIN) | Division of Southeast Imports (DSEI) | |
| 5/22/2024 | 62GDJ99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2023 | 61CDK99ANTI-ANEMIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/13/2021 | 61CCK99ANTI-ANEMIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2019 | 54ACK02VITAMIN B1 (THIAMINE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/6/2018 | 61VCK99ANTI-FLATULENT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/18/2017 | 63VCY02HYDROQUINONE (DEPIGMENTOR) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LABORATORIOS GROSSMAN S.A's FDA import refusal history?
LABORATORIOS GROSSMAN S.A (FEI: 3012845835) has 12 FDA import refusal record(s) in our database, spanning from 10/18/2017 to 1/22/2026.
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. LABORATORIOS GROSSMAN S.A's FEI number is 3012845835.
What types of violations has LABORATORIOS GROSSMAN S.A received?
LABORATORIOS GROSSMAN S.A has been cited for 2 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 LABORATORIOS GROSSMAN S.A come from?
All FDA import refusal data for LABORATORIOS GROSSMAN S.A 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.