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Serpaprosa S.A. De C.V. / Aeroflash

⚠️ Moderate Risk

FEI: 3006194078 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3006194078

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Avenida Ermita Iztapalapa N 576, Col. Pueblo Mexicaltzingo, Iztapalapa, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
5/24/2007
Latest Refusal
5/24/2007
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

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
5/24/2007
61WCA47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/24/2007
61WCA47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Serpaprosa S.A. De C.V. / Aeroflash's FDA import refusal history?

Serpaprosa S.A. De C.V. / Aeroflash (FEI: 3006194078) has 2 FDA import refusal record(s) in our database, spanning from 5/24/2007 to 5/24/2007.

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. Serpaprosa S.A. De C.V. / Aeroflash's FEI number is 3006194078.

What types of violations has Serpaprosa S.A. De C.V. / Aeroflash received?

Serpaprosa S.A. De C.V. / Aeroflash 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 Serpaprosa S.A. De C.V. / Aeroflash come from?

All FDA import refusal data for Serpaprosa S.A. De C.V. / Aeroflash 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.