Quinto Polyclinic
⚠️ High Risk
FEI: 3005584415 • Malabonmalabon • PHILIPPINES
FEI Number
3005584415
Location
Malabonmalabon
Country
PHILIPPINESAddress
37 Naval Stflores Hulo, , Malabonmalabon, , Philippines
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 |
|---|---|---|---|
| 6/8/2006 | 60QCH39LEVOXADROL HCL (ANESTHETIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/8/2006 | 60CCA49PHENYLPROPANOLAMINE HCL (ADRENERGIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/8/2006 | 62UCH11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/8/2006 | 64HCA99EXPECTORANT N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/8/2006 | 61PCA09GLIPIZIDE (ANTI-DIABETIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/8/2006 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Quinto Polyclinic's FDA import refusal history?
Quinto Polyclinic (FEI: 3005584415) has 6 FDA import refusal record(s) in our database, spanning from 6/8/2006 to 6/8/2006.
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. Quinto Polyclinic's FEI number is 3005584415.
What types of violations has Quinto Polyclinic received?
Quinto Polyclinic 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 Quinto Polyclinic come from?
All FDA import refusal data for Quinto Polyclinic 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.