Psitek
✅ Low Risk
FEI: 3004881621 • Bellville, Western Cape • SOUTH AFRICA
FEI Number
3004881621
Location
Bellville, Western Cape
Country
SOUTH AFRICAAddress
3fl Tiger Park 5willie Van Schoor Av, , Bellville, Western Cape, South Africa
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/25/2005 | 63HAH22SENNA (CATHARTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Psitek's FDA import refusal history?
Psitek (FEI: 3004881621) has 1 FDA import refusal record(s) in our database, spanning from 1/25/2005 to 1/25/2005.
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. Psitek's FEI number is 3004881621.
What types of violations has Psitek received?
Psitek has been cited for 1 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 Psitek come from?
All FDA import refusal data for Psitek 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.