Spoldzielnia Mleczarska MLEKOVITA

⚠️ Moderate Risk

FEI: 3003250685 • Wysokie Mazowieckie, Podlaskie • POLAND

FEI

FEI Number

3003250685

📍

Location

Wysokie Mazowieckie, Podlaskie

🇵🇱

Country

POLAND

🏢

Address

Ul. Ludowa 122, , Wysokie Mazowieckie, Podlaskie, Poland

Moderate Risk

FDA Import Risk Assessment

36.0

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

5/19/2016

Latest Refusal

6/18/2013

Earliest Refusal

Score Breakdown

Violation Severity

59.0×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

24.0×10%

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

Violation Summary

2185×

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.

2384×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

3243×

NO ENGLISH

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

4823×

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.

832×

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).

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

Refusal History

Date	Product	Violations	Division
5/19/2016	09CVS09MILK, PLAIN	62NEEDS FCE 83NO PROCESS	Division of Southeast Imports (DSEI)
2/12/2016	09CVS09MILK, PLAIN	62NEEDS FCE 83NO PROCESS	Florida District Office (FLA-DO)
6/18/2013	12BHP11PASTEURIZED PROCESS CHEESE SPREAD	218LIST INGRE 238UNSAFE ADD 324NO ENGLISH 482NUTRIT LBL	New York District Office (NYK-DO)
6/18/2013	12BHP12PASTEURIZED PROCESS CHEESE SPREAD WITH FRUITS, VEGETABLES OR MEATS	218LIST INGRE 238UNSAFE ADD 324NO ENGLISH 482NUTRIT LBL	New York District Office (NYK-DO)
6/18/2013	12BHP12PASTEURIZED PROCESS CHEESE SPREAD WITH FRUITS, VEGETABLES OR MEATS	218LIST INGRE 238UNSAFE ADD	New York District Office (NYK-DO)
6/18/2013	12BHP11PASTEURIZED PROCESS CHEESE SPREAD	218LIST INGRE 238UNSAFE ADD	New York District Office (NYK-DO)
6/18/2013	12BHP12PASTEURIZED PROCESS CHEESE SPREAD WITH FRUITS, VEGETABLES OR MEATS	11UNSAFE COL 218LIST INGRE 324NO ENGLISH 482NUTRIT LBL	New York District Office (NYK-DO)

Frequently Asked Questions

What is Spoldzielnia Mleczarska MLEKOVITA's FDA import refusal history?

Spoldzielnia Mleczarska MLEKOVITA (FEI: 3003250685) has 7 FDA import refusal record(s) in our database, spanning from 6/18/2013 to 5/19/2016.

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. Spoldzielnia Mleczarska MLEKOVITA's FEI number is 3003250685.

What types of violations has Spoldzielnia Mleczarska MLEKOVITA received?

Spoldzielnia Mleczarska MLEKOVITA has been cited for 7 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 Spoldzielnia Mleczarska MLEKOVITA come from?

All FDA import refusal data for Spoldzielnia Mleczarska MLEKOVITA 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.