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Bap Medical

⚠️ Moderate Risk

FEI: 3007919248 • Rumbeke, West-vlaanderen • BELGIUM

FEI

FEI Number

3007919248

📍

Location

Rumbeke, West-vlaanderen

🇧🇪

Country

BELGIUM
🏢

Address

Bornstraat 6, , Rumbeke, West-vlaanderen, Belgium

Moderate Risk

FDA Import Risk Assessment

43.0
LowModerateHighCritical

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

Statistics

5
Total Refusals
3
Unique Violations
12/12/2011
Latest Refusal
12/12/2011
Earliest Refusal

Score Breakdown

Violation Severity
73.3×40%
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

754×

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).

1181×

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).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
12/12/2011
62FIS99ANTI-INFECTIVE, TOPICAL N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/12/2011
62FIS99ANTI-INFECTIVE, TOPICAL N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/12/2011
62FIS99ANTI-INFECTIVE, TOPICAL N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/12/2011
79MDAELASTOMER, SILICONE, FOR SCAR MANAGEMENT
118NOT LISTED
341REGISTERED
New Orleans District Office (NOL-DO)
12/12/2011
62FIS99ANTI-INFECTIVE, TOPICAL N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Bap Medical's FDA import refusal history?

Bap Medical (FEI: 3007919248) has 5 FDA import refusal record(s) in our database, spanning from 12/12/2011 to 12/12/2011.

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. Bap Medical's FEI number is 3007919248.

What types of violations has Bap Medical received?

Bap Medical has been cited for 3 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 Bap Medical come from?

All FDA import refusal data for Bap Medical 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.