ARMSTRONG LABORATORIOS DE MEXICOS.
⚠️ High Risk
FEI: 3014306569 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3014306569
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Avenida Division Del Norte 3311, Col. La Candelaria, Coyoacan, Ciudad De Mexico, Ciudad de Mexico, 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 |
|---|---|---|---|
| 1/9/2026 | 66JDY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2019 | 60LCY14CARBAMAZEPINE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/14/2019 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ARMSTRONG LABORATORIOS DE MEXICOS.'s FDA import refusal history?
ARMSTRONG LABORATORIOS DE MEXICOS. (FEI: 3014306569) has 3 FDA import refusal record(s) in our database, spanning from 3/14/2019 to 1/9/2026.
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 LABORATORIOS DE MEXICOS.'s FEI number is 3014306569.
What types of violations has ARMSTRONG LABORATORIOS DE MEXICOS. received?
ARMSTRONG LABORATORIOS DE MEXICOS. 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 LABORATORIOS DE MEXICOS. come from?
All FDA import refusal data for ARMSTRONG LABORATORIOS DE MEXICOS. 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.