Armstrong Laboratories
⚠️ High Risk
FEI: 3008077123 • Coyoacan • MEXICO
FEI Number
3008077123
Location
Coyoacan
Country
MEXICOAddress
Av Division Del Norte 3311candelaria, , Coyoacan, , Mexico
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 |
|---|---|---|---|
| 7/14/2025 | 62ODY24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2024 | 62OCA24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2023 | 60LCY17CLONIXIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/13/2022 | 61MCA30VALPROATE SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/11/2022 | 60SCY13MAGNESIUM CARBONATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Armstrong Laboratories's FDA import refusal history?
Armstrong Laboratories (FEI: 3008077123) has 5 FDA import refusal record(s) in our database, spanning from 10/11/2022 to 7/14/2025.
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. Armstrong Laboratories's FEI number is 3008077123.
What types of violations has Armstrong Laboratories received?
Armstrong 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 Armstrong Laboratories come from?
All FDA import refusal data for Armstrong 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.