De Acero Sa. De Cv.
⚠️ Moderate Risk
FEI: 3001151948 • Garza Garcia, NL. • MEXICO
FEI Number
3001151948
Location
Garza Garcia, NL.
Country
MEXICOAddress
Ave. Lazaro Cardenas 2333, Col. Valle Ote., Garza Garcia, NL., Mexico
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
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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
Frequently Asked Questions
What is De Acero Sa. De Cv.'s FDA import refusal history?
De Acero Sa. De Cv. (FEI: 3001151948) has 2 FDA import refusal record(s) in our database, spanning from 12/3/2001 to 12/3/2001.
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. De Acero Sa. De Cv.'s FEI number is 3001151948.
What types of violations has De Acero Sa. De Cv. received?
De Acero Sa. De Cv. has been cited for 2 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 De Acero Sa. De Cv. come from?
All FDA import refusal data for De Acero Sa. De Cv. 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.