Merck And Co.
⚠️ Moderate Risk
FEI: 3003641509 • Makati, National Capital Region • PHILIPPINES
FEI Number
3003641509
Location
Makati, National Capital Region
Country
PHILIPPINESAddress
8767 Paseo De Roxas, , Makati, National Capital Region, Philippines
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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 |
|---|---|---|---|
| 8/9/2024 | 62OCY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Merck And Co.'s FDA import refusal history?
Merck And Co. (FEI: 3003641509) has 1 FDA import refusal record(s) in our database, spanning from 8/9/2024 to 8/9/2024.
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. Merck And Co.'s FEI number is 3003641509.
What types of violations has Merck And Co. received?
Merck And Co. 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 Merck And Co. come from?
All FDA import refusal data for Merck And Co. 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.