Raisio Nutrition Ltd

⚠️ High Risk

FEI: 3007199631 • Raisio, Varsinais-Suomi • FINLAND

FEI

FEI Number

3007199631

📍

Location

Raisio, Varsinais-Suomi

🇫🇮

Country

FINLAND

🏢

Address

PL 101, , Raisio, Varsinais-Suomi, Finland

High Risk

FDA Import Risk Assessment

54.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

3/28/2011

Latest Refusal

11/5/2010

Earliest Refusal

Score Breakdown

Violation Severity

80.0×40%

Refusal Volume

41.3×30%

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

8310×

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.

627×

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).

1812×

UNDER PRC

The article appears to have inadequate processing in having been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.

2602×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

31601×

NONRSP-VER

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer for this thermally processed low acid food packaged in a hermetically sealed container pursuant to 21 CFR 108.35 (c)(2) appears to be inadequate to protect the public health.

31611×

NONRSP-PRC

The article appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer pursuant to 21 CFR 108.35(c)(2) appears to be inadequate to protect the public health.

Refusal History

Date	Product	Violations	Division
3/28/2011	30YFE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	83NO PROCESS	Los Angeles District Office (LOS-DO)
3/28/2011	30YFE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	83NO PROCESS	Los Angeles District Office (LOS-DO)
3/28/2011	30YFE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	83NO PROCESS	Los Angeles District Office (LOS-DO)
2/10/2011	30YFE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/10/2011	30YFE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
2/10/2011	30YFE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	62NEEDS FCE 83NO PROCESS	New York District Office (NYK-DO)
12/8/2010	30YFE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	3161NONRSP-PRC 62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
12/8/2010	30YFE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	3160NONRSP-VER 62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
12/8/2010	30YFE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
12/8/2010	30YFE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
11/5/2010	30YFE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	181UNDER PRC 260FALSE	Los Angeles District Office (LOS-DO)
11/5/2010	30YFE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	181UNDER PRC 260FALSE	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Raisio Nutrition Ltd's FDA import refusal history?

Raisio Nutrition Ltd (FEI: 3007199631) has 12 FDA import refusal record(s) in our database, spanning from 11/5/2010 to 3/28/2011.

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. Raisio Nutrition Ltd's FEI number is 3007199631.

What types of violations has Raisio Nutrition Ltd received?

Raisio Nutrition Ltd has been cited for 6 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 Raisio Nutrition Ltd come from?

All FDA import refusal data for Raisio Nutrition Ltd 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.