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Maximo Gomez P, SA

⚠️ Moderate Risk

FEI: 2000038371 • Santo Domingo, DO-01 • DOMINICAN REPUBLIC

FEI

FEI Number

2000038371

📍

Location

Santo Domingo, DO-01

🇩🇴
🏢

Address

Parque Industrial Duarte Km. 22 1/2, , Santo Domingo, DO-01, Dominican Republic

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
10/20/2009
Latest Refusal
10/20/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
10/20/2009
62HCY03TROVAFLOXACIN/AZITHROMYCIN (ANTI-MICROBIAL)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/20/2009
62FCY53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
10/20/2009
62FCY53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Maximo Gomez P, SA's FDA import refusal history?

Maximo Gomez P, SA (FEI: 2000038371) has 3 FDA import refusal record(s) in our database, spanning from 10/20/2009 to 10/20/2009.

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. Maximo Gomez P, SA's FEI number is 2000038371.

What types of violations has Maximo Gomez P, SA received?

Maximo Gomez P, SA 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 Maximo Gomez P, SA come from?

All FDA import refusal data for Maximo Gomez P, SA 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.