Krasnaya Zvezda Chemical-Pharmaceutical Factory
⚠️ Moderate Risk
FEI: 3008488727 • Kharkov • UKRAINE
FEI Number
3008488727
Location
Kharkov
Country
UKRAINEAddress
1 Gordievskogo Str, , Kharkov, , Ukraine
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
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).
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.
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).
Refusal History
Frequently Asked Questions
What is Krasnaya Zvezda Chemical-Pharmaceutical Factory's FDA import refusal history?
Krasnaya Zvezda Chemical-Pharmaceutical Factory (FEI: 3008488727) has 2 FDA import refusal record(s) in our database, spanning from 12/2/2010 to 6/1/2012.
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. Krasnaya Zvezda Chemical-Pharmaceutical Factory's FEI number is 3008488727.
What types of violations has Krasnaya Zvezda Chemical-Pharmaceutical Factory received?
Krasnaya Zvezda Chemical-Pharmaceutical Factory 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 Krasnaya Zvezda Chemical-Pharmaceutical Factory come from?
All FDA import refusal data for Krasnaya Zvezda Chemical-Pharmaceutical Factory 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.