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Industrial Forms Sa De Cv

⚠️ Moderate Risk

FEI: 3005952330 • Guadalajara • MEXICO

FEI

FEI Number

3005952330

📍

Location

Guadalajara

🇲🇽

Country

MEXICO
🏢

Address

Privada Santa Catarina No 72 El, , Guadalajara, , Mexico

Moderate Risk

FDA Import Risk Assessment

41.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
11/14/2006
Latest Refusal
11/14/2006
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
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

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).

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).

Refusal History

DateProductViolationsDivision
11/14/2006
64LCK19DEXAMETHASONE (GLUCOCORTICOID)
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)
11/14/2006
64LCK03BETAMETHASONE (GLUCOCORTICOID)
27DRUG GMPS
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Industrial Forms Sa De Cv's FDA import refusal history?

Industrial Forms Sa De Cv (FEI: 3005952330) has 2 FDA import refusal record(s) in our database, spanning from 11/14/2006 to 11/14/2006.

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. Industrial Forms Sa De Cv's FEI number is 3005952330.

What types of violations has Industrial Forms Sa De Cv received?

Industrial Forms Sa De Cv 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 Industrial Forms Sa De Cv come from?

All FDA import refusal data for Industrial Forms Sa De Cv 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.