Gelpharma S.A. de C.V.
⚠️ High Risk
FEI: 3010158287 • Zapopan, Jalisco • MEXICO
FEI Number
3010158287
Location
Zapopan, Jalisco
Country
MEXICOAddress
Av. Paseo Del Pacifico No. 380 Guadalajara Technology Park, Zapopan, Zapopan, Jalisco, 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. 801.15(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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/4/2025 | 66SCA27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2025 | 62ACY04CALCITRIOL (ANTI-HYPERCALCEMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2024 | 65QCE22METHOCARBAMOL (RELAXANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/2/2024 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/2/2024 | 54YCC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/2/2024 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/2/2024 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/2/2024 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/2/2024 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/12/2024 | 61TDB29SCOPOLAMINE (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/10/2024 | 54FFY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 64XDY11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2024 | 64XDA11ISOTRETINOIN (KERATOLYTIC) | Division of Southeast Imports (DSEI) | |
| 4/15/2024 | 62GDA41IBUPROFEN (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 2/27/2024 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/7/2023 | 62GDY41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2023 | 62GCY41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/7/2023 | 66GDA25DIMETHICONE 350 (SURGICAL/PROSTHETIC AID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/6/2022 | 64XCA11ISOTRETINOIN (KERATOLYTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/9/2020 | 54AGA16VITAMIN E (TOCOPHEROL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 62TDB99ANTI-SECRETORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2019 | 66FCA99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/23/2019 | 66SCY27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2019 | 62TDB99ANTI-SECRETORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/16/2018 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/28/2017 | 62GCA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/23/2016 | 62GDA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/26/2013 | 54ACH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Gelpharma S.A. de C.V.'s FDA import refusal history?
Gelpharma S.A. de C.V. (FEI: 3010158287) has 29 FDA import refusal record(s) in our database, spanning from 7/26/2013 to 8/4/2025.
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. Gelpharma S.A. de C.V.'s FEI number is 3010158287.
What types of violations has Gelpharma S.A. de C.V. received?
Gelpharma 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 Gelpharma S.A. de C.V. come from?
All FDA import refusal data for Gelpharma 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.