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Regis Sp. z.o.o, Bochnia Plant

⚠️ Moderate Risk

FEI: 3009111304 • Bochnia, Malopolskie • POLAND

FEI

FEI Number

3009111304

📍

Location

Bochnia, Malopolskie

🇵🇱

Country

POLAND
🏢

Address

Ul. Lany 6, , Bochnia, Malopolskie, Poland

Moderate Risk

FDA Import Risk Assessment

38.6
LowModerateHighCritical

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

Statistics

10
Total Refusals
4
Unique Violations
8/7/2012
Latest Refusal
8/7/2012
Earliest Refusal

Score Breakdown

Violation Severity
42.5×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

21810×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

32110×

LACKS N/C

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

48210×

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.

48810×

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.

Refusal History

DateProductViolationsDivision
8/7/2012
41BGF99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
488HEALTH C
New Orleans District Office (NOL-DO)
8/7/2012
41BGF99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
488HEALTH C
New Orleans District Office (NOL-DO)
8/7/2012
41BEF99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
488HEALTH C
New Orleans District Office (NOL-DO)
8/7/2012
41BGF99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
488HEALTH C
New Orleans District Office (NOL-DO)
8/7/2012
41BGF99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
488HEALTH C
New Orleans District Office (NOL-DO)
8/7/2012
41BGF99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
488HEALTH C
New Orleans District Office (NOL-DO)
8/7/2012
41BDF99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
488HEALTH C
New Orleans District Office (NOL-DO)
8/7/2012
41BDF99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
488HEALTH C
New Orleans District Office (NOL-DO)
8/7/2012
41BDF99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
488HEALTH C
New Orleans District Office (NOL-DO)
8/7/2012
41BGF99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
488HEALTH C
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Regis Sp. z.o.o, Bochnia Plant's FDA import refusal history?

Regis Sp. z.o.o, Bochnia Plant (FEI: 3009111304) has 10 FDA import refusal record(s) in our database, spanning from 8/7/2012 to 8/7/2012.

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. Regis Sp. z.o.o, Bochnia Plant's FEI number is 3009111304.

What types of violations has Regis Sp. z.o.o, Bochnia Plant received?

Regis Sp. z.o.o, Bochnia Plant 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 Regis Sp. z.o.o, Bochnia Plant come from?

All FDA import refusal data for Regis Sp. z.o.o, Bochnia Plant 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.