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ELABORADO LABORATORIOS

⚠️ Moderate Risk

FEI: 3012877356 • Bogota • COLOMBIA

FEI

FEI Number

3012877356

📍

Location

Bogota

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 75 No 85 33, , Bogota, , Colombia

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/14/2016
Latest Refusal
11/14/2016
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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).

Refusal History

DateProductViolationsDivision
11/14/2016
64LCY03BETAMETHASONE (GLUCOCORTICOID)
27DRUG GMPS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ELABORADO LABORATORIOS's FDA import refusal history?

ELABORADO LABORATORIOS (FEI: 3012877356) has 1 FDA import refusal record(s) in our database, spanning from 11/14/2016 to 11/14/2016.

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. ELABORADO LABORATORIOS's FEI number is 3012877356.

What types of violations has ELABORADO LABORATORIOS received?

ELABORADO LABORATORIOS 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 ELABORADO LABORATORIOS come from?

All FDA import refusal data for ELABORADO LABORATORIOS 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.