ImportRefusal LogoImportRefusal

REMARCABILA SRL

⚠️ Moderate Risk

FEI: 3009219431 • Terebna, Edinet • MOLDOVA

FEI

FEI Number

3009219431

📍

Location

Terebna, Edinet

🇲🇩

Country

MOLDOVA
🏢

Address

Teatrala Street 8, , Terebna, Edinet, Moldova

Moderate Risk

FDA Import Risk Assessment

38.3
LowModerateHighCritical

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

Statistics

4
Total Refusals
5
Unique Violations
12/2/2013
Latest Refusal
2/11/2013
Earliest Refusal

Score Breakdown

Violation Severity
66.3×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

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).

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.

2181×

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.

2601×

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.

4821×

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.

Refusal History

DateProductViolationsDivision
12/2/2013
23ECT12WALNUTS, BLACK, ENGLISH OR PERSIAN, SPREAD
218LIST INGRE
260FALSE
482NUTRIT LBL
Seattle District Office (SEA-DO)
2/11/2013
24ACE51PEAS
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)
2/11/2013
24KCI06SQUASH, SUMMER, WITH SAUCE
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)
2/11/2013
24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE)
62NEEDS FCE
New York District Office (NYK-DO)

Frequently Asked Questions

What is REMARCABILA SRL's FDA import refusal history?

REMARCABILA SRL (FEI: 3009219431) has 4 FDA import refusal record(s) in our database, spanning from 2/11/2013 to 12/2/2013.

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. REMARCABILA SRL's FEI number is 3009219431.

What types of violations has REMARCABILA SRL received?

REMARCABILA SRL has been cited for 5 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 REMARCABILA SRL come from?

All FDA import refusal data for REMARCABILA SRL 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.