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Mario Manzano

⚠️ Moderate Risk

FEI: 3003559282 • Saltillo • MEXICO

FEI

FEI Number

3003559282

📍

Location

Saltillo

🇲🇽

Country

MEXICO
🏢

Address

Calle Primera 86 Col Issste, , Saltillo, , Mexico

Moderate Risk

FDA Import Risk Assessment

42.5
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

5
Total Refusals
2
Unique Violations
2/19/2002
Latest Refusal
2/19/2002
Earliest Refusal

Score Breakdown

Violation Severity
72.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1793×

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.

752×

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

DateProductViolationsDivision
2/19/2002
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
179AGR RX
New Orleans District Office (NOL-DO)
2/19/2002
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
179AGR RX
New Orleans District Office (NOL-DO)
2/19/2002
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
179AGR RX
New Orleans District Office (NOL-DO)
2/19/2002
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/19/2002
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Mario Manzano's FDA import refusal history?

Mario Manzano (FEI: 3003559282) has 5 FDA import refusal record(s) in our database, spanning from 2/19/2002 to 2/19/2002.

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. Mario Manzano's FEI number is 3003559282.

What types of violations has Mario Manzano received?

Mario Manzano 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 Mario Manzano come from?

All FDA import refusal data for Mario Manzano 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.