Foster Clark Products Ltd.
⚠️ Moderate Risk
FEI: 3001258595 • San Gwann, Not Applicable • MALTA
FEI Number
3001258595
Location
San Gwann, Not Applicable
Country
MALTAAddress
UB 50 Industrial Estate, , San Gwann, Not Applicable, Malta
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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.
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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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.
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)).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/9/2021 | 35CET99CUSTARD PUDDING (PIE) MIX, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 9/9/2021 | 35CET99CUSTARD PUDDING (PIE) MIX, N.E.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 | 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) | Detroit District Office (DET-DO) | |
| 1/23/2002 | 50BCT01COLOR FOR FOOD (NOT CERTIFIED) | Detroit District Office (DET-DO) | |
| 1/23/2002 | 35DDT03CARAMEL PUDDING (PIE FILLING) MIX (NOT CUSTARD) | Detroit District Office (DET-DO) | |
| 1/23/2002 | 30AFT02BEVERAGE BASE, CITRUS | Detroit District Office (DET-DO) | |
| 1/23/2002 | 30AFT06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT | Detroit District Office (DET-DO) | |
| 1/23/2002 | 30AFT02BEVERAGE BASE, CITRUS | Detroit District Office (DET-DO) | |
| 1/23/2002 | 30AFT06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT | Detroit District Office (DET-DO) | |
| 1/23/2002 | 30AFT05BEVERAGE BASE, PIT FRUIT | Detroit District Office (DET-DO) | |
| 1/23/2002 | 35CET99CUSTARD PUDDING (PIE) MIX, N.E.C. | Detroit District Office (DET-DO) | |
| 1/23/2002 | 21CGT99MIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C. | Detroit District Office (DET-DO) | |
| 1/23/2002 | 45LC99FLAVORING AGENTS AND ADJUVANTS (FOOD ADDITIVES FOR HUMAN USE) | Detroit District Office (DET-DO) | |
| 1/22/2002 | 35AFT01GELATIN, FLAVORED | Detroit District Office (DET-DO) | |
| 1/22/2002 | 35ADT01GELATIN, FLAVORED | Detroit District Office (DET-DO) | |
| 1/22/2002 | 35ADT01GELATIN, FLAVORED | Detroit District Office (DET-DO) | |
| 1/22/2002 | 35ADT01GELATIN, FLAVORED | Detroit District Office (DET-DO) | |
| 1/22/2002 | 35ADT01GELATIN, FLAVORED | Detroit District Office (DET-DO) | |
| 1/22/2002 | 35ADT01GELATIN, FLAVORED | Detroit District Office (DET-DO) | |
| 1/22/2002 | 35ADT01GELATIN, FLAVORED | Detroit District Office (DET-DO) | |
| 1/22/2002 | 35ADT01GELATIN, FLAVORED | Detroit District Office (DET-DO) | |
| 12/17/2001 | 21CGE02CITRUS, MIXED, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED | Los Angeles District Office (LOS-DO) | |
| 12/17/2001 | 03YET99OTHER BAKERY PRODUCTS, N.E.C. | 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.