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Milano Foods & Biscuits

⚠️ Moderate Risk

FEI: 3001584140 • Concord, Ontario • CANADA

FEI

FEI Number

3001584140

📍

Location

Concord, Ontario

🇨🇦

Country

CANADA
🏢

Address

51 Jardin Dr, , Concord, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

31.4
LowModerateHighCritical

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

Statistics

10
Total Refusals
9
Unique Violations
3/25/2009
Latest Refusal
10/25/2005
Earliest Refusal

Score Breakdown

Violation Severity
42.2×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
29.3×10%
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

21810×

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.

4825×

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.

33203×

TRANSFAT

The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].

3213×

LACKS N/C

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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

641×

YELLOW #5

The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.

3201×

LACKS FIRM

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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

3281×

USUAL NAME

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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

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).

Refusal History

DateProductViolationsDivision
3/25/2009
03HGT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
11UNSAFE COL
218LIST INGRE
482NUTRIT LBL
64YELLOW #5
Detroit District Office (DET-DO)
7/21/2008
03HMT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
218LIST INGRE
3320TRANSFAT
New York District Office (NYK-DO)
7/21/2008
03HMT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
218LIST INGRE
321LACKS N/C
3320TRANSFAT
New York District Office (NYK-DO)
7/21/2008
03HMT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
218LIST INGRE
321LACKS N/C
3320TRANSFAT
New York District Office (NYK-DO)
7/21/2008
03HMT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
218LIST INGRE
New York District Office (NYK-DO)
7/21/2008
03HMT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
218LIST INGRE
New York District Office (NYK-DO)
11/15/2005
03HGT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
New York District Office (NYK-DO)
10/25/2005
03HGT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
218LIST INGRE
482NUTRIT LBL
Detroit District Office (DET-DO)
10/25/2005
03HGT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
218LIST INGRE
328USUAL NAME
473LABELING
482NUTRIT LBL
Detroit District Office (DET-DO)
10/25/2005
03HGT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
218LIST INGRE
320LACKS FIRM
473LABELING
482NUTRIT LBL
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Milano Foods & Biscuits's FDA import refusal history?

Milano Foods & Biscuits (FEI: 3001584140) has 10 FDA import refusal record(s) in our database, spanning from 10/25/2005 to 3/25/2009.

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. Milano Foods & Biscuits's FEI number is 3001584140.

What types of violations has Milano Foods & Biscuits received?

Milano Foods & Biscuits has been cited for 9 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 Milano Foods & Biscuits come from?

All FDA import refusal data for Milano Foods & Biscuits 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.