ImportRefusal LogoImportRefusal

Yuridia Romero T

⚠️ Moderate Risk

FEI: 3010632689 • Atlixco, Pue • MEXICO

FEI

FEI Number

3010632689

📍

Location

Atlixco, Pue

🇲🇽

Country

MEXICO
🏢

Address

Avv Agustin Perez # 261 Atlixco Puebla, , Atlixco, Pue, Mexico

Moderate Risk

FDA Import Risk Assessment

32.9
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
2/26/2014
Latest Refusal
2/26/2014
Earliest Refusal

Score Breakdown

Violation Severity
64.0×40%
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

4722×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

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
2/26/2014
62YCY07MELOXICAM (ANTI-INFLAMMATORY, PART II)
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)
2/26/2014
62GCK18DICLOFENAC SODIUM (ANTI-INFLAMMATORY)
27DRUG GMPS
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Yuridia Romero T's FDA import refusal history?

Yuridia Romero T (FEI: 3010632689) has 2 FDA import refusal record(s) in our database, spanning from 2/26/2014 to 2/26/2014.

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. Yuridia Romero T's FEI number is 3010632689.

What types of violations has Yuridia Romero T received?

Yuridia Romero T has been cited for 3 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 Yuridia Romero T come from?

All FDA import refusal data for Yuridia Romero T 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.