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ASA BV

⚠️ Moderate Risk

FEI: 3013855293 • Amersfoort, Utrecht • NETHERLANDS

FEI

FEI Number

3013855293

📍

Location

Amersfoort, Utrecht

🇳🇱
🏢

Address

Stadsring 157, , Amersfoort, Utrecht, Netherlands

Moderate Risk

FDA Import Risk Assessment

33.4
LowModerateHighCritical

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

Statistics

5
Total Refusals
4
Unique Violations
3/29/2019
Latest Refusal
3/29/2019
Earliest Refusal

Score Breakdown

Violation Severity
49.4×40%
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

4735×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4825×

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.

4885×

HEALTH C

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 bears an unauthorized nutrient content/health claim.

751×

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
3/29/2019
54ABE90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
473LABELING
482NUTRIT LBL
488HEALTH C
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/29/2019
54ABE90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
473LABELING
482NUTRIT LBL
488HEALTH C
Division of Southeast Imports (DSEI)
3/29/2019
54ABE90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
473LABELING
482NUTRIT LBL
488HEALTH C
Division of Southeast Imports (DSEI)
3/29/2019
54ABE90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
473LABELING
482NUTRIT LBL
488HEALTH C
Division of Southeast Imports (DSEI)
3/29/2019
54ABE90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
473LABELING
482NUTRIT LBL
488HEALTH C
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ASA BV's FDA import refusal history?

ASA BV (FEI: 3013855293) has 5 FDA import refusal record(s) in our database, spanning from 3/29/2019 to 3/29/2019.

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. ASA BV's FEI number is 3013855293.

What types of violations has ASA BV received?

ASA BV has been cited for 4 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 ASA BV come from?

All FDA import refusal data for ASA 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.