Laboratorio Y Drogueria Qualipharma Sa
⚠️ High Risk
FEI: 3011190555 • Guatemala • GUATEMALA
FEI Number
3011190555
Location
Guatemala
Country
GUATEMALAAddress
Km 20.5 Aldea Santa Ines, , Guatemala, , Guatemala
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/12/2023 | 62FDY53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2023 | 64HCY99EXPECTORANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2023 | 62UDY11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2023 | 62FCY47CARBAMIDE PEROXIDE (SOL) (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2023 | 62GCY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2023 | 61XCY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2023 | 62GDY94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2023 | 56ICY76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2023 | 61HCY43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2023 | 60LCY01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2023 | 64LCY03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2023 | 61FDY60FOSFOMYCIN TROMETHAMINE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/13/2023 | 61WDM47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 7/13/2023 | 61WDJ47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 10/7/2015 | 61XBL16DEXCHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Laboratorio Y Drogueria Qualipharma Sa's FDA import refusal history?
Laboratorio Y Drogueria Qualipharma Sa (FEI: 3011190555) has 15 FDA import refusal record(s) in our database, spanning from 10/7/2015 to 12/12/2023.
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. Laboratorio Y Drogueria Qualipharma Sa's FEI number is 3011190555.
What types of violations has Laboratorio Y Drogueria Qualipharma Sa received?
Laboratorio Y Drogueria Qualipharma Sa 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 Laboratorio Y Drogueria Qualipharma Sa come from?
All FDA import refusal data for Laboratorio Y Drogueria Qualipharma 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.