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RS FARMA S.A. DE C.V.

⚠️ Moderate Risk

FEI: 3023999295 • Zapopan • MEXICO

FEI

FEI Number

3023999295

📍

Location

Zapopan

🇲🇽

Country

MEXICO
🏢

Address

Cp 45133 El Centinela, , Zapopan, , Mexico

Moderate Risk

FDA Import Risk Assessment

44.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/9/2022
Latest Refusal
11/9/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
22.5×20%
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
11/9/2022
56YOY99ANTIBIOTIC N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is RS FARMA S.A. DE C.V.'s FDA import refusal history?

RS FARMA S.A. DE C.V. (FEI: 3023999295) has 1 FDA import refusal record(s) in our database, spanning from 11/9/2022 to 11/9/2022.

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. RS FARMA S.A. DE C.V.'s FEI number is 3023999295.

What types of violations has RS FARMA S.A. DE C.V. received?

RS FARMA 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 RS FARMA S.A. DE C.V. come from?

All FDA import refusal data for RS FARMA 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.