Biotiki
✅ Low Risk
FEI: 3004703599 • Moskaw, RU-MOW • RUSSIA
FEI Number
3004703599
Location
Moskaw, RU-MOW
Country
RUSSIAAddress
Luganskaya St. #9, , Moskaw, RU-MOW, Russia
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/16/2010 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3260NO ENGLISH | New York District Office (NYK-DO) |
| 1/26/2010 | 66YCA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Biotiki's FDA import refusal history?
Biotiki (FEI: 3004703599) has 2 FDA import refusal record(s) in our database, spanning from 1/26/2010 to 9/16/2010.
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. Biotiki's FEI number is 3004703599.
What types of violations has Biotiki received?
Biotiki has been cited for 4 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 Biotiki come from?
All FDA import refusal data for Biotiki 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.