ENSON LABORATORIES, INC.
⚠️ Moderate Risk
FEI: 3015504474 • Meycauayan, Central Luzon • PHILIPPINES
FEI Number
3015504474
Location
Meycauayan, Central Luzon
Country
PHILIPPINESAddress
Phoenix Road, , Meycauayan, Central Luzon, 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/13/2022 | 56CPY73CEPHALEXIN HYDROCHLORIDE (CEPHALOSPORINS) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 1/13/2022 | 64HPY01BROMHEXINE HCL (EXPECTORANT) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 1/13/2022 | 61GPY40SPIRAMYCIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ENSON LABORATORIES, INC.'s FDA import refusal history?
ENSON LABORATORIES, INC. (FEI: 3015504474) has 3 FDA import refusal record(s) in our database, spanning from 1/13/2022 to 1/13/2022.
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. ENSON LABORATORIES, INC.'s FEI number is 3015504474.
What types of violations has ENSON LABORATORIES, INC. received?
ENSON LABORATORIES, INC. 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 ENSON LABORATORIES, INC. come from?
All FDA import refusal data for ENSON LABORATORIES, INC. 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.