ACHE LABORATORIES
⚠️ High Risk
FEI: 3038211291 • Cabo De Santo Agostin • BRAZIL
FEI Number
3038211291
Location
Cabo De Santo Agostin
Country
BRAZILAddress
Rodouia Pe, 09, , Cabo De Santo Agostin, , Brazil
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 |
|---|---|---|---|
| 7/22/2025 | 61XCL42ANTAZOLINE PHOSPHATE/NAPHAZOLINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ACHE LABORATORIES's FDA import refusal history?
ACHE LABORATORIES (FEI: 3038211291) has 1 FDA import refusal record(s) in our database, spanning from 7/22/2025 to 7/22/2025.
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. ACHE LABORATORIES's FEI number is 3038211291.
What types of violations has ACHE LABORATORIES received?
ACHE LABORATORIES 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 ACHE LABORATORIES come from?
All FDA import refusal data for ACHE LABORATORIES 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.