Tybah Sewak
✅ Low Risk
FEI: 3007684466 • unknown • SAUDI ARABIA
FEI Number
3007684466
Location
unknown
Country
SAUDI ARABIAAddress
Al-qassim-Albadayee, P.O. Box 384, unknown, , Saudi Arabia
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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
Frequently Asked Questions
What is Tybah Sewak's FDA import refusal history?
Tybah Sewak (FEI: 3007684466) has 1 FDA import refusal record(s) in our database, spanning from 7/21/2009 to 7/21/2009.
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. Tybah Sewak's FEI number is 3007684466.
What types of violations has Tybah Sewak received?
Tybah Sewak has been cited for 2 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 Tybah Sewak come from?
All FDA import refusal data for Tybah Sewak 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.