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Serono de Mexico S.A. de C.V.

⚠️ Moderate Risk

FEI: 3004053375 • D.F. • MEXICO

FEI

FEI Number

3004053375

📍

Location

D.F.

🇲🇽

Country

MEXICO
🏢

Address

Av. Rio Churubusco, Col. El Sifon, , Mexico, D.F., , Mexico

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/18/2003
Latest Refusal
2/18/2003
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

751×

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
2/18/2003
64RCK22SOMATROPIN (RDNA ORIGIN) (HORMONE)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Serono de Mexico S.A. de C.V.'s FDA import refusal history?

Serono de Mexico S.A. de C.V. (FEI: 3004053375) has 1 FDA import refusal record(s) in our database, spanning from 2/18/2003 to 2/18/2003.

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. Serono de Mexico S.A. de C.V.'s FEI number is 3004053375.

What types of violations has Serono de Mexico S.A. de C.V. received?

Serono de Mexico S.A. de C.V. 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 Serono de Mexico S.A. de C.V. come from?

All FDA import refusal data for Serono de Mexico S.A. de C.V. 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.