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Lab San

⚠️ Moderate Risk

FEI: 3003461007 • Santo • DOMINICAN REPUBLIC

FEI

FEI Number

3003461007

📍

Location

Santo

🇩🇴
🏢

Address

The, , Santo, , Dominican Republic

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/18/2001
Latest Refusal
11/18/2001
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

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
11/18/2001
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/18/2001
66VBO99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/18/2001
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Lab San's FDA import refusal history?

Lab San (FEI: 3003461007) has 3 FDA import refusal record(s) in our database, spanning from 11/18/2001 to 11/18/2001.

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 San's FEI number is 3003461007.

What types of violations has Lab San received?

Lab San 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 San come from?

All FDA import refusal data for Lab San 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.