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Disorga Sa

⚠️ Moderate Risk

FEI: 3011279455 • Guatemala • GUATEMALA

FEI

FEI Number

3011279455

📍

Location

Guatemala

🇬🇹

Country

GUATEMALA
🏢

Address

Zona 6 De Mixco, , Guatemala, , Guatemala

Moderate Risk

FDA Import Risk Assessment

49.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
2/13/2015
Latest Refusal
2/13/2015
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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).

Refusal History

DateProductViolationsDivision
2/13/2015
53UG01BABY PRODUCTS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS)
75UNAPPROVED
Florida District Office (FLA-DO)
2/13/2015
56BCK52PENCILLIN BENZATHINE SYNTHETIC PENICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
Florida District Office (FLA-DO)
2/13/2015
60QCK40LIDOCAINE HCL (ANESTHETIC)
75UNAPPROVED
Florida District Office (FLA-DO)
2/13/2015
62GCK99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
2/13/2015
56DCO20GENTAMICIN (AMINOGLYCOSIDES)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Disorga Sa's FDA import refusal history?

Disorga Sa (FEI: 3011279455) has 5 FDA import refusal record(s) in our database, spanning from 2/13/2015 to 2/13/2015.

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. Disorga Sa's FEI number is 3011279455.

What types of violations has Disorga Sa received?

Disorga 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 Disorga Sa come from?

All FDA import refusal data for Disorga 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.