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Provitus Sc

⚠️ Moderate Risk

FEI: 3000243439 • Radzymin, Mazowieckie • POLAND

FEI

FEI Number

3000243439

📍

Location

Radzymin, Mazowieckie

🇵🇱

Country

POLAND
🏢

Address

Ul. Weteranow 82, , Radzymin, Mazowieckie, Poland

Moderate Risk

FDA Import Risk Assessment

40.1
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
6/4/2015
Latest Refusal
5/5/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
3.3×10%
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

833×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

622×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

Refusal History

DateProductViolationsDivision
6/4/2015
25JCI01CARROT (ROOT & TUBER VEGETABLE)
62NEEDS FCE
83NO PROCESS
Division of Northern Border Imports (DNBI)
4/5/2004
25PCF99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.
62NEEDS FCE
Chicago District Office (CHI-DO)
5/5/2003
25PCF99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.
83NO PROCESS
Chicago District Office (CHI-DO)
5/5/2003
25PCF99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.
83NO PROCESS
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Provitus Sc's FDA import refusal history?

Provitus Sc (FEI: 3000243439) has 4 FDA import refusal record(s) in our database, spanning from 5/5/2003 to 6/4/2015.

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. Provitus Sc's FEI number is 3000243439.

What types of violations has Provitus Sc received?

Provitus Sc 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 Provitus Sc come from?

All FDA import refusal data for Provitus Sc 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.