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Food Industry - Vitaminka Prilep

⚠️ Moderate Risk

FEI: 3001028074 • Prilep, Prilep • MACEDONIA

FEI

FEI Number

3001028074

📍

Location

Prilep, Prilep

🇲🇰

Country

MACEDONIA
🏢

Address

Lece Koteski 60, , Prilep, Prilep, Macedonia

Moderate Risk

FDA Import Risk Assessment

43.2
LowModerateHighCritical

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

Statistics

10
Total Refusals
8
Unique Violations
3/28/2016
Latest Refusal
9/26/2005
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
9.5×10%
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

94×

SALMONELLA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.

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.

623×

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).

4822×

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.

2182×

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.

2492×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

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).

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
3/28/2016
28AGT54PEPPER,BLACK, WHOLE (SPICE)
9SALMONELLA
New York District Office (NYK-DO)
3/28/2016
28BGT54PEPPER, BLACK, GROUND, CRACKED (SPICE)
9SALMONELLA
New York District Office (NYK-DO)
12/15/2011
28BGT54PEPPER, BLACK, GROUND, CRACKED (SPICE)
249FILTHY
9SALMONELLA
New York District Office (NYK-DO)
12/15/2011
28BGT54PEPPER, BLACK, GROUND, CRACKED (SPICE)
249FILTHY
9SALMONELLA
New York District Office (NYK-DO)
3/9/2009
03JGT02CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS
218LIST INGRE
482NUTRIT LBL
Detroit District Office (DET-DO)
3/9/2009
03MFT99COOKIE,BISCUIT,WAFER DOUGH, N.E.C.
11UNSAFE COL
218LIST INGRE
482NUTRIT LBL
Detroit District Office (DET-DO)
4/4/2007
65RAY18SODIUM BICARBONATE (REPLENISHER)
118NOT LISTED
New York District Office (NYK-DO)
9/26/2005
24FCY08PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE)
62NEEDS FCE
83NO PROCESS
Chicago District Office (CHI-DO)
9/26/2005
24FCY20CUCUMBERS (FRUIT USED AS VEGETABLE)
62NEEDS FCE
83NO PROCESS
Chicago District Office (CHI-DO)
9/26/2005
25JCI05PARSNIP (ROOT & TUBER VEGETABLE)
62NEEDS FCE
83NO PROCESS
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Food Industry - Vitaminka Prilep's FDA import refusal history?

Food Industry - Vitaminka Prilep (FEI: 3001028074) has 10 FDA import refusal record(s) in our database, spanning from 9/26/2005 to 3/28/2016.

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. Food Industry - Vitaminka Prilep's FEI number is 3001028074.

What types of violations has Food Industry - Vitaminka Prilep received?

Food Industry - Vitaminka Prilep has been cited for 8 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 Food Industry - Vitaminka Prilep come from?

All FDA import refusal data for Food Industry - Vitaminka Prilep 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.