Rosem

⚠️ High Risk

FEI: 3004110531 • Riga, Rigas rajons • LATVIA

FEI

FEI Number

3004110531

📍

Location

Riga, Rigas rajons

🇱🇻

Country

LATVIA

🏢

Address

Aleksandra Caka iela 33, , Riga, Rigas rajons, Latvia

High Risk

FDA Import Risk Assessment

58.1

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

1/25/2005

Latest Refusal

2/25/2004

Earliest Refusal

Score Breakdown

Violation Severity

80.0×40%

Refusal Volume

53.6×30%

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

Violation Summary

8327×

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.

6219×

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

Date	Product	Violations	Division
1/25/2005	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	83NO PROCESS	Los Angeles District Office (LOS-DO)
1/25/2005	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	83NO PROCESS	Los Angeles District Office (LOS-DO)
1/25/2005	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	83NO PROCESS	Los Angeles District Office (LOS-DO)
1/25/2005	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	83NO PROCESS	Los Angeles District Office (LOS-DO)
1/25/2005	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	83NO PROCESS	Los Angeles District Office (LOS-DO)
1/25/2005	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	83NO PROCESS	Los Angeles District Office (LOS-DO)
1/25/2005	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	83NO PROCESS	Los Angeles District Office (LOS-DO)
1/25/2005	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	83NO PROCESS	Los Angeles District Office (LOS-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/25/2004	25PCI99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)

Frequently Asked Questions

What is Rosem's FDA import refusal history?

Rosem (FEI: 3004110531) has 27 FDA import refusal record(s) in our database, spanning from 2/25/2004 to 1/25/2005.

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. Rosem's FEI number is 3004110531.

What types of violations has Rosem received?

Rosem 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 Rosem come from?

All FDA import refusal data for Rosem 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.