MEDIGAPER
⚠️ High Risk
FEI: 3020323942 • Zapopan • MEXICO
FEI Number
3020323942
Location
Zapopan
Country
MEXICOAddress
Av Santa Esther 109 Santa Margarita, , Zapopan, , 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/21/2023 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/21/2023 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/2/2021 | 62YDY07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2021 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2021 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2021 | 60SCY23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2021 | 64HCY01BROMHEXINE HCL (EXPECTORANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MEDIGAPER's FDA import refusal history?
MEDIGAPER (FEI: 3020323942) has 7 FDA import refusal record(s) in our database, spanning from 12/2/2021 to 9/21/2023.
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. MEDIGAPER's FEI number is 3020323942.
What types of violations has MEDIGAPER received?
MEDIGAPER 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 MEDIGAPER come from?
All FDA import refusal data for MEDIGAPER 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.