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IFA PHARMACEUTICALS CELTICS MEX

⚠️ Moderate Risk

FEI: 3013589577 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3013589577

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Av Insurgentes Sur No 2 Piso 9 Oficina 902, Pueblo Loreto Y Campamento, Alvaro Obregon, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

45.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/12/2023
Latest Refusal
1/12/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
26.0×20%
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
1/12/2023
61KCY40PIPERIDOLATE HCL (ANTI-CHOLINERGIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is IFA PHARMACEUTICALS CELTICS MEX's FDA import refusal history?

IFA PHARMACEUTICALS CELTICS MEX (FEI: 3013589577) has 1 FDA import refusal record(s) in our database, spanning from 1/12/2023 to 1/12/2023.

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. IFA PHARMACEUTICALS CELTICS MEX's FEI number is 3013589577.

What types of violations has IFA PHARMACEUTICALS CELTICS MEX received?

IFA PHARMACEUTICALS CELTICS MEX 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 IFA PHARMACEUTICALS CELTICS MEX come from?

All FDA import refusal data for IFA PHARMACEUTICALS CELTICS MEX 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.