Osmed Sas

⚠️ Moderate Risk

FEI: 3012031742 • Bogota • COLOMBIA

FEI

FEI Number

3012031742

📍

Location

Bogota

🇨🇴

Country

COLOMBIA

🏢

Address

Cr 26 45c-23, , Bogota, , Colombia

Moderate Risk

FDA Import Risk Assessment

47.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

8/31/2016

Latest Refusal

8/31/2016

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

57.2×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

11834×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

328034×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

Date	Product	Violations	Division
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)
8/31/2016	87MOOORTHOPEDIC IMPLANT MATERIAL	118NOT LISTED 3280FRNMFGREG	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Osmed Sas's FDA import refusal history?

Osmed Sas (FEI: 3012031742) has 34 FDA import refusal record(s) in our database, spanning from 8/31/2016 to 8/31/2016.

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. Osmed Sas's FEI number is 3012031742.

What types of violations has Osmed Sas received?

Osmed Sas 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 Osmed Sas come from?

All FDA import refusal data for Osmed Sas 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.