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Ventura Tellez

⚠️ Moderate Risk

FEI: 3008603837 • Col. Puebla Centro, Puebla • MEXICO

FEI

FEI Number

3008603837

📍

Location

Col. Puebla Centro, Puebla

🇲🇽

Country

MEXICO
🏢

Address

Sur 2305-Ccentropuebla 11, Puebla, Col. Puebla Centro, Puebla, Mexico

Moderate Risk

FDA Import Risk Assessment

39.8
LowModerateHighCritical

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

Statistics

5
Total Refusals
4
Unique Violations
12/15/2010
Latest Refusal
12/15/2010
Earliest Refusal

Score Breakdown

Violation Severity
65.4×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

4725×

NO ENGLISH

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

755×

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).

272×

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).

1861×

INSANITARY

The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
12/15/2010
66VCC99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)
12/15/2010
66VCC99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)
12/15/2010
66VCC99MISCELLANEOUS PATENT MEDICINES, ETC.
186INSANITARY
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)
12/15/2010
65RAK12POTASSIC SALINE (INJECTION) (REPLENISHER)
27DRUG GMPS
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)
12/15/2010
66VCK99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Ventura Tellez's FDA import refusal history?

Ventura Tellez (FEI: 3008603837) has 5 FDA import refusal record(s) in our database, spanning from 12/15/2010 to 12/15/2010.

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. Ventura Tellez's FEI number is 3008603837.

What types of violations has Ventura Tellez received?

Ventura Tellez has been cited for 4 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 Ventura Tellez come from?

All FDA import refusal data for Ventura Tellez 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.