ImportRefusal LogoImportRefusal

Astip Ortopedik Tibbi Malzelme

⚠️ Moderate Risk

FEI: 3006631441 • Alsancak • TURKEY

FEI

FEI Number

3006631441

📍

Location

Alsancak

🇹🇷

Country

TURKEY
🏢

Address

1420 Sk. No. 98/202, , Alsancak, , Turkey

Moderate Risk

FDA Import Risk Assessment

42.0
LowModerateHighCritical

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

Statistics

11
Total Refusals
1
Unique Violations
2/20/2008
Latest Refusal
2/20/2008
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
40.0×30%
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

© ImportRefusal.com Original Analysis

Violation Summary

11811×

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).

Refusal History

DateProductViolationsDivision
2/20/2008
87MATORTHOSIS, FIXATION, SPINAL CERVICAL INTERVERTEBRAL BODY
118NOT LISTED
Southwest Import District Office (SWI-DO)
2/20/2008
87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC
118NOT LISTED
Southwest Import District Office (SWI-DO)
2/20/2008
87MATORTHOSIS, FIXATION, SPINAL CERVICAL INTERVERTEBRAL BODY
118NOT LISTED
Southwest Import District Office (SWI-DO)
2/20/2008
87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC
118NOT LISTED
Southwest Import District Office (SWI-DO)
2/20/2008
87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC
118NOT LISTED
Southwest Import District Office (SWI-DO)
2/20/2008
87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC
118NOT LISTED
Southwest Import District Office (SWI-DO)
2/20/2008
87NDJSCREW, FIXATION, BONE, NON-SPINAL, METALLIC
118NOT LISTED
Southwest Import District Office (SWI-DO)
2/20/2008
87MZZPROSTHESIS, FEMORAL NAIL
118NOT LISTED
Southwest Import District Office (SWI-DO)
2/20/2008
87NDHNAIL, FIXATION, BONE, METALLIC
118NOT LISTED
Southwest Import District Office (SWI-DO)
2/20/2008
87NDHNAIL, FIXATION, BONE, METALLIC
118NOT LISTED
Southwest Import District Office (SWI-DO)
2/20/2008
87MZZPROSTHESIS, FEMORAL NAIL
118NOT LISTED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Astip Ortopedik Tibbi Malzelme's FDA import refusal history?

Astip Ortopedik Tibbi Malzelme (FEI: 3006631441) has 11 FDA import refusal record(s) in our database, spanning from 2/20/2008 to 2/20/2008.

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. Astip Ortopedik Tibbi Malzelme's FEI number is 3006631441.

What types of violations has Astip Ortopedik Tibbi Malzelme received?

Astip Ortopedik Tibbi Malzelme 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 Astip Ortopedik Tibbi Malzelme come from?

All FDA import refusal data for Astip Ortopedik Tibbi Malzelme 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.