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SANTE PHARMA BV

Low Risk

FEI: 3014168273 • Deventer, Overijssel • NETHERLANDS

FEI

FEI Number

3014168273

📍

Location

Deventer, Overijssel

🇳🇱
🏢

Address

Arnsbergstraat 11, , Deventer, Overijssel, Netherlands

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
5/10/2019
Latest Refusal
5/10/2019
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

38641×

NCONTACT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
5/10/2019
54FYH99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
3864NCONTACT
482NUTRIT LBL
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is SANTE PHARMA BV's FDA import refusal history?

SANTE PHARMA BV (FEI: 3014168273) has 1 FDA import refusal record(s) in our database, spanning from 5/10/2019 to 5/10/2019.

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. SANTE PHARMA BV's FEI number is 3014168273.

What types of violations has SANTE PHARMA BV received?

SANTE PHARMA BV 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 SANTE PHARMA BV come from?

All FDA import refusal data for SANTE PHARMA BV 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.