Ktc Edibles Ltd
⚠️ Moderate Risk
FEI: 1000365755 • Wednesbury • UNITED KINGDOM
FEI Number
1000365755
Location
Wednesbury
Country
UNITED KINGDOMAddress
Beacon Wks Friar Pk Rd, , Wednesbury, , United Kingdom
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
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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.
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).
DRUG COLOR
The article appears to be a color additive the intended use of which is for the purpose of coloring only, and its packaging and labeling do not conform to regulations issued under section 721.
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.
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/30/2014 | 28JGT99MIXED SPICES AND SEASONING WITH SALT, N.E.C. | San Francisco District Office (SAN-DO) | |
| 3/9/2011 | 26CCT09SESAME OIL, REFINED, SINGLE INGREDIENT | Seattle District Office (SEA-DO) | |
| 12/20/2010 | 50DHY05FD&C YELLOW #6 | San Francisco District Office (SAN-DO) | |
| 12/20/2010 | 50DHY04FD&C YELLOW #5 | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 12/20/2010 | 50LHY99COLORS FOR FOOD USE (NOT CERTIFIED), N.E.C. | 11UNSAFE COL | San Francisco District Office (SAN-DO) |
| 8/13/2009 | 28EGH99MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C. | 11UNSAFE COL | New York District Office (NYK-DO) |
| 9/25/2006 | 28FET04CURRY POWDER, GROUND, CRACKED, WITHOUT SALT | San Francisco District Office (SAN-DO) | |
| 8/5/2006 | 63HAL08CASTOR OIL (CATHARTIC) | San Francisco District Office (SAN-DO) | |
| 7/13/2006 | 23EGP05COCONUT, SPREAD | New York District Office (NYK-DO) | |
| 6/29/2005 | 28BFT08CAPSICUMS (CAYENNE CHILI, HOT PEPPERS), GROUND, CRACKED (SPICE) | 9SALMONELLA | San Francisco District Office (SAN-DO) |
| 12/5/2003 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 12/5/2003 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 12/5/2003 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Ktc Edibles Ltd's FDA import refusal history?
Ktc Edibles Ltd (FEI: 1000365755) has 13 FDA import refusal record(s) in our database, spanning from 12/5/2003 to 10/30/2014.
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. Ktc Edibles Ltd's FEI number is 1000365755.
What types of violations has Ktc Edibles Ltd received?
Ktc Edibles Ltd has been cited for 12 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 Ktc Edibles Ltd come from?
All FDA import refusal data for Ktc Edibles 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.