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Lab Lobefer

⚠️ Moderate Risk

FEI: 3002716792 • unknown • DOMINICAN REPUBLIC

FEI

FEI Number

3002716792

📍

Location

unknown

🇩🇴
🏢

Address

unknown, , unknown, , Dominican Republic

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
6/10/2004
Latest Refusal
10/24/2001
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
11.4×10%
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

753×

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).

Refusal History

DateProductViolationsDivision
6/10/2004
53UC99COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS), N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
10/24/2001
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Juan District Office (SJN-DO)
10/24/2001
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
San Juan District Office (SJN-DO)

Frequently Asked Questions

What is Lab Lobefer's FDA import refusal history?

Lab Lobefer (FEI: 3002716792) has 3 FDA import refusal record(s) in our database, spanning from 10/24/2001 to 6/10/2004.

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. Lab Lobefer's FEI number is 3002716792.

What types of violations has Lab Lobefer received?

Lab Lobefer 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 Lab Lobefer come from?

All FDA import refusal data for Lab Lobefer 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.