P J Wijesekera
⚠️ High Risk
FEI: 3010488769 • Kandy, Kandy • SRI LANKA
FEI Number
3010488769
Location
Kandy, Kandy
Country
SRI LANKAAddress
4731 Aruppola Rd, , Kandy, Kandy, Sri Lanka
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2013 | 65JDB11ETHISTERONE (PROGESTIN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/9/2013 | 64NDB04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/9/2013 | 61BDB02CYPROTERONE ACETATE (ANTI-ANDROGEN) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/9/2013 | 61TCA31DOMPERIDONE | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/9/2013 | 60SCA22FAMOTIDINE (ANTACID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/9/2013 | 62SDJ02ADAPALENE (ANTI-SEBORRHEIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/9/2013 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/9/2013 | 61FDJ33ERTHROMYCIN ETHYLCARBONATE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is P J Wijesekera's FDA import refusal history?
P J Wijesekera (FEI: 3010488769) has 8 FDA import refusal record(s) in our database, spanning from 12/9/2013 to 12/9/2013.
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. P J Wijesekera's FEI number is 3010488769.
What types of violations has P J Wijesekera received?
P J Wijesekera 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 P J Wijesekera come from?
All FDA import refusal data for P J Wijesekera 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.