Laboratorio Farmaceutico San Joaquin Roxfarma SA
⚠️ High Risk
FEI: 3014020922 • Los Olivos, Lima • PERU
FEI Number
3014020922
Location
Los Olivos, Lima
Country
PERUAddress
Av. Alfredo Mendiola 5648, , Los Olivos, Lima, Peru
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 |
|---|---|---|---|
| 5/14/2018 | 61VAK01SIMETHICONE (ANTI-FLATULENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/14/2018 | 56DBO41NEOMYCIN SULFATE (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/14/2018 | 61LDO08HEPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/14/2018 | 60SAK06BISMUTH (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/14/2018 | 61WAO52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/14/2018 | 61VAK01SIMETHICONE (ANTI-FLATULENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/14/2018 | 62GAK41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Laboratorio Farmaceutico San Joaquin Roxfarma SA's FDA import refusal history?
Laboratorio Farmaceutico San Joaquin Roxfarma SA (FEI: 3014020922) has 7 FDA import refusal record(s) in our database, spanning from 5/14/2018 to 5/14/2018.
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. Laboratorio Farmaceutico San Joaquin Roxfarma SA's FEI number is 3014020922.
What types of violations has Laboratorio Farmaceutico San Joaquin Roxfarma SA received?
Laboratorio Farmaceutico San Joaquin Roxfarma SA 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 Laboratorio Farmaceutico San Joaquin Roxfarma SA come from?
All FDA import refusal data for Laboratorio Farmaceutico San Joaquin Roxfarma SA 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.