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Foster Clark Products Ltd.

⚠️ Moderate Risk

FEI: 3001258595 • San Gwann, Not Applicable • MALTA

FEI

FEI Number

3001258595

📍

Location

San Gwann, Not Applicable

🇲🇹

Country

MALTA
🏢

Address

UB 50 Industrial Estate, , San Gwann, Not Applicable, Malta

Moderate Risk

FDA Import Risk Assessment

41.6
LowModerateHighCritical

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

Statistics

31
Total Refusals
8
Unique Violations
9/9/2021
Latest Refusal
12/17/2001
Earliest Refusal

Score Breakdown

Violation Severity
51.6×40%
Refusal Volume
55.8×30%
Recency
13.2×20%
Frequency
15.7×10%
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

21825×

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.

1121×

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).

48220×

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.

47315×

LABELING

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

649×

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.

3214×

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.

2564×

INCONSPICU

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

2761×

PRESRV LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a chemical preservative and it fails to bear labeling stating that fact including its function.

Refusal History

DateProductViolationsDivision
9/9/2021
35CET99CUSTARD PUDDING (PIE) MIX, N.E.C.
11UNSAFE COL
256INCONSPICU
321LACKS N/C
Division of Northern Border Imports (DNBI)
9/9/2021
35CET99CUSTARD PUDDING (PIE) MIX, N.E.C.
11UNSAFE COL
218LIST INGRE
256INCONSPICU
321LACKS N/C
Division of Northern Border Imports (DNBI)
10/16/2012
13BYY99CUSTARD, N.E.C.
11UNSAFE COL
Cincinnati District Office (CIN-DO)
9/13/2012
13BYY99CUSTARD, N.E.C.
11UNSAFE COL
Cincinnati District Office (CIN-DO)
7/21/2010
45LY99FLAVORING AGENTS AND ADJUVANTS (FOOD ADDITIVES FOR HUMAN USE)
218LIST INGRE
New York District Office (NYK-DO)
7/21/2010
45LY99FLAVORING AGENTS AND ADJUVANTS (FOOD ADDITIVES FOR HUMAN USE)
218LIST INGRE
New York District Office (NYK-DO)
7/21/2010
45LY99FLAVORING AGENTS AND ADJUVANTS (FOOD ADDITIVES FOR HUMAN USE)
218LIST INGRE
New York District Office (NYK-DO)
3/12/2010
45LY99FLAVORING AGENTS AND ADJUVANTS (FOOD ADDITIVES FOR HUMAN USE)
218LIST INGRE
New York District Office (NYK-DO)
1/23/2002
02HET02CORN STARCH
473LABELING
482NUTRIT LBL
Detroit District Office (DET-DO)
1/23/2002
45RE99LEAVENING AGENTS (FOOD ADDITIVES FOR HUMAN USE)
256INCONSPICU
Detroit District Office (DET-DO)
1/23/2002
35DDT10VANILLA PUDDING (PIE FILLING) MIX (NOT CUSTARD)
218LIST INGRE
482NUTRIT LBL
Detroit District Office (DET-DO)
1/23/2002
50BCT01COLOR FOR FOOD (NOT CERTIFIED)
11UNSAFE COL
321LACKS N/C
Detroit District Office (DET-DO)
1/23/2002
35DDT03CARAMEL PUDDING (PIE FILLING) MIX (NOT CUSTARD)
11UNSAFE COL
218LIST INGRE
482NUTRIT LBL
64YELLOW #5
Detroit District Office (DET-DO)
1/23/2002
30AFT02BEVERAGE BASE, CITRUS
11UNSAFE COL
218LIST INGRE
473LABELING
482NUTRIT LBL
64YELLOW #5
Detroit District Office (DET-DO)
1/23/2002
30AFT06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT
11UNSAFE COL
218LIST INGRE
473LABELING
482NUTRIT LBL
64YELLOW #5
Detroit District Office (DET-DO)
1/23/2002
30AFT02BEVERAGE BASE, CITRUS
11UNSAFE COL
218LIST INGRE
473LABELING
482NUTRIT LBL
64YELLOW #5
Detroit District Office (DET-DO)
1/23/2002
30AFT06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT
11UNSAFE COL
218LIST INGRE
473LABELING
482NUTRIT LBL
64YELLOW #5
Detroit District Office (DET-DO)
1/23/2002
30AFT05BEVERAGE BASE, PIT FRUIT
11UNSAFE COL
218LIST INGRE
473LABELING
482NUTRIT LBL
64YELLOW #5
Detroit District Office (DET-DO)
1/23/2002
35CET99CUSTARD PUDDING (PIE) MIX, N.E.C.
11UNSAFE COL
218LIST INGRE
473LABELING
482NUTRIT LBL
64YELLOW #5
Detroit District Office (DET-DO)
1/23/2002
21CGT99MIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C.
11UNSAFE COL
218LIST INGRE
276PRESRV LBL
473LABELING
482NUTRIT LBL
Detroit District Office (DET-DO)
1/23/2002
45LC99FLAVORING AGENTS AND ADJUVANTS (FOOD ADDITIVES FOR HUMAN USE)
11UNSAFE COL
218LIST INGRE
256INCONSPICU
Detroit District Office (DET-DO)
1/22/2002
35AFT01GELATIN, FLAVORED
218LIST INGRE
482NUTRIT LBL
Detroit District Office (DET-DO)
1/22/2002
35ADT01GELATIN, FLAVORED
218LIST INGRE
473LABELING
482NUTRIT LBL
Detroit District Office (DET-DO)
1/22/2002
35ADT01GELATIN, FLAVORED
11UNSAFE COL
218LIST INGRE
473LABELING
482NUTRIT LBL
64YELLOW #5
Detroit District Office (DET-DO)
1/22/2002
35ADT01GELATIN, FLAVORED
11UNSAFE COL
218LIST INGRE
473LABELING
482NUTRIT LBL
64YELLOW #5
Detroit District Office (DET-DO)
1/22/2002
35ADT01GELATIN, FLAVORED
11UNSAFE COL
218LIST INGRE
473LABELING
482NUTRIT LBL
Detroit District Office (DET-DO)
1/22/2002
35ADT01GELATIN, FLAVORED
11UNSAFE COL
218LIST INGRE
473LABELING
482NUTRIT LBL
Detroit District Office (DET-DO)
1/22/2002
35ADT01GELATIN, FLAVORED
11UNSAFE COL
218LIST INGRE
473LABELING
482NUTRIT LBL
Detroit District Office (DET-DO)
1/22/2002
35ADT01GELATIN, FLAVORED
11UNSAFE COL
218LIST INGRE
473LABELING
482NUTRIT LBL
Detroit District Office (DET-DO)
12/17/2001
21CGE02CITRUS, MIXED, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
12/17/2001
03YET99OTHER BAKERY PRODUCTS, N.E.C.
11UNSAFE COL
218LIST INGRE
482NUTRIT LBL
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Foster Clark Products Ltd.'s FDA import refusal history?

Foster Clark Products Ltd. (FEI: 3001258595) has 31 FDA import refusal record(s) in our database, spanning from 12/17/2001 to 9/9/2021.

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. Foster Clark Products Ltd.'s FEI number is 3001258595.

What types of violations has Foster Clark Products Ltd. received?

Foster Clark Products Ltd. has been cited for 8 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 Foster Clark Products Ltd. come from?

All FDA import refusal data for Foster Clark Products 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.