LOTTE Wedel sp. Z.O.O.

⚠️ Moderate Risk

FEI: 3008404504 • Warsaw, Mazowieckie • POLAND

FEI

FEI Number

3008404504

📍

Location

Warsaw, Mazowieckie

🇵🇱

Country

POLAND

🏢

Address

Ul. Jana Zamoyskiego 28/30, , Warsaw, Mazowieckie, Poland

Moderate Risk

FDA Import Risk Assessment

47.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/6/2012

Latest Refusal

2/6/2012

Earliest Refusal

Score Breakdown

Violation Severity

80.0×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

60.0×10%

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

626×

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).

836×

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.

Refusal History

Date	Product	Violations	Division
2/6/2012	24FGI20CUCUMBERS (FRUIT USED AS VEGETABLE)	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/6/2012	24FGI20CUCUMBERS (FRUIT USED AS VEGETABLE)	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/6/2012	16AGT21HERRING	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/6/2012	16AGT73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22')	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/6/2012	16AGT16FLOUNDER (ARROWTOOTH, DAB, FLUKE)	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/6/2012	16AGT21HERRING	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)

Frequently Asked Questions

What is LOTTE Wedel sp. Z.O.O.'s FDA import refusal history?

LOTTE Wedel sp. Z.O.O. (FEI: 3008404504) has 6 FDA import refusal record(s) in our database, spanning from 2/6/2012 to 2/6/2012.

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. LOTTE Wedel sp. Z.O.O.'s FEI number is 3008404504.

What types of violations has LOTTE Wedel sp. Z.O.O. received?

LOTTE Wedel sp. Z.O.O. 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 LOTTE Wedel sp. Z.O.O. come from?

All FDA import refusal data for LOTTE Wedel sp. Z.O.O. 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.