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Mercedes Beltran

⚠️ Moderate Risk

FEI: 3006058553 • Torreontorreon • MEXICO

FEI

FEI Number

3006058553

📍

Location

Torreontorreon

🇲🇽

Country

MEXICO
🏢

Address

C. Jose Ma Del Bosque 524 Nte, , Torreontorreon, , Mexico

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
1/22/2007
Latest Refusal
1/22/2007
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

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).

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

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
1/22/2007
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
336INCONSPICU
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Mercedes Beltran's FDA import refusal history?

Mercedes Beltran (FEI: 3006058553) has 1 FDA import refusal record(s) in our database, spanning from 1/22/2007 to 1/22/2007.

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. Mercedes Beltran's FEI number is 3006058553.

What types of violations has Mercedes Beltran received?

Mercedes Beltran 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 Mercedes Beltran come from?

All FDA import refusal data for Mercedes Beltran 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.