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FABRICADO POR MERCK SHARP DOHME

✅ Low Risk

FEI: 3016778979 • Bogota • COLOMBIA

FEI

FEI Number

3016778979

📍

Location

Bogota

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 127 A 53a 45 Torr, , Bogota, , Colombia

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
12/4/2020
Latest Refusal
12/4/2020
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

38731×

708NOREG

It has been determined the drug was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
12/4/2020
61PCA68SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC)
3873708NOREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FABRICADO POR MERCK SHARP DOHME's FDA import refusal history?

FABRICADO POR MERCK SHARP DOHME (FEI: 3016778979) has 1 FDA import refusal record(s) in our database, spanning from 12/4/2020 to 12/4/2020.

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. FABRICADO POR MERCK SHARP DOHME's FEI number is 3016778979.

What types of violations has FABRICADO POR MERCK SHARP DOHME received?

FABRICADO POR MERCK SHARP DOHME 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 FABRICADO POR MERCK SHARP DOHME come from?

All FDA import refusal data for FABRICADO POR MERCK SHARP DOHME 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.