Zaharni Zavodi PLC
⚠️ Moderate Risk
FEI: 3008153840 • Gorna Oryahovitsa, Veliko Tarnovo • BULGARIA
FEI Number
3008153840
Location
Gorna Oryahovitsa, Veliko Tarnovo
Country
BULGARIAAddress
29 Sveti knyaz Boris I, , Gorna Oryahovitsa, Veliko Tarnovo, Bulgaria
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
NO ENGLISH
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)).
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).
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.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/16/2013 | 33KGE99SOFT CANDY WITH NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 218LIST INGRE | New York District Office (NYK-DO) |
| 2/10/2012 | 33KGE99SOFT CANDY WITH NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 473LABELING | New York District Office (NYK-DO) |
| 2/10/2012 | 33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 324NO ENGLISH | New York District Office (NYK-DO) |
| 2/10/2012 | 33KGE99SOFT CANDY WITH NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 324NO ENGLISH | New York District Office (NYK-DO) |
| 2/10/2012 | 33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 274COLOR LBLG | New York District Office (NYK-DO) |
| 4/12/2006 | 33EGH99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 11UNSAFE COL | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Zaharni Zavodi PLC's FDA import refusal history?
Zaharni Zavodi PLC (FEI: 3008153840) has 6 FDA import refusal record(s) in our database, spanning from 4/12/2006 to 4/16/2013.
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. Zaharni Zavodi PLC's FEI number is 3008153840.
What types of violations has Zaharni Zavodi PLC received?
Zaharni Zavodi PLC 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 Zaharni Zavodi PLC come from?
All FDA import refusal data for Zaharni Zavodi PLC 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.