Plantex Biotech
⚠️ Moderate Risk
FEI: 3011804859 • Kovno, Kaunas County • LITHUANIA
FEI Number
3011804859
Location
Kovno, Kaunas County
Country
LITHUANIAAddress
Breslaujos G. 3, , Kovno, Kaunas County, Lithuania
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
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)).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/13/2016 | 54HAL99FATS AND LIPID SUBSTANCES, N.E.C. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 6/8/2016 | 54HAL99FATS AND LIPID SUBSTANCES, N.E.C. | 256INCONSPICU | Cincinnati District Office (CIN-DO) |
| 6/6/2016 | 54HAL99FATS AND LIPID SUBSTANCES, N.E.C. | 256INCONSPICU | Cincinnati District Office (CIN-DO) |
| 5/9/2016 | 33SYY99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/9/2016 | 33SYY99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Plantex Biotech's FDA import refusal history?
Plantex Biotech (FEI: 3011804859) has 5 FDA import refusal record(s) in our database, spanning from 5/9/2016 to 7/13/2016.
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. Plantex Biotech's FEI number is 3011804859.
What types of violations has Plantex Biotech received?
Plantex Biotech has been cited for 3 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 Plantex Biotech come from?
All FDA import refusal data for Plantex Biotech 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.