WERMAR PHARMACEUTICALS SA DE CV
⚠️ High Risk
FEI: 3012523806 • Pueblo Santa Maria La Alta, Puebla • MEXICO
FEI Number
3012523806
Location
Pueblo Santa Maria La Alta, Puebla
Country
MEXICOAddress
Enrique Gonzalez Martin, Tlacotepec De Benito Juarez, Pueblo Santa Maria La Alta, Puebla, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/3/2019 | 61NCY69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2019 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/12/2018 | 61WDA46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/2/2017 | 61NDY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/28/2017 | 62KDC10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2017 | 66YCH99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2017 | 61MCA99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/19/2017 | 62KDB10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2017 | 61NCY69GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/16/2016 | 60LBB01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is WERMAR PHARMACEUTICALS SA DE CV's FDA import refusal history?
WERMAR PHARMACEUTICALS SA DE CV (FEI: 3012523806) has 10 FDA import refusal record(s) in our database, spanning from 8/16/2016 to 4/3/2019.
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. WERMAR PHARMACEUTICALS SA DE CV's FEI number is 3012523806.
What types of violations has WERMAR PHARMACEUTICALS SA DE CV received?
WERMAR PHARMACEUTICALS SA DE CV has been cited for 1 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 WERMAR PHARMACEUTICALS SA DE CV come from?
All FDA import refusal data for WERMAR PHARMACEUTICALS SA DE CV 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.