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Citi

⚠️ Moderate Risk

FEI: 3009568219 • Guadalajaraguadalajara • MEXICO

FEI

FEI Number

3009568219

📍

Location

Guadalajaraguadalajara

🇲🇽

Country

MEXICO
🏢

Address

Av La Paz 1281, , Guadalajaraguadalajara, , Mexico

Moderate Risk

FDA Import Risk Assessment

42.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/26/2012
Latest Refusal
7/26/2012
Earliest Refusal

Score Breakdown

Violation Severity
86.7×40%
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).

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
7/26/2012
56ICY10ERYTHROMYCIN (MACROLIDES)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
7/26/2012
56CCK70CEFTRIAXONE SODIUM (CEPHALOSPORINS)
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Citi's FDA import refusal history?

Citi (FEI: 3009568219) has 2 FDA import refusal record(s) in our database, spanning from 7/26/2012 to 7/26/2012.

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. Citi's FEI number is 3009568219.

What types of violations has Citi received?

Citi 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 Citi come from?

All FDA import refusal data for Citi 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.