Pt Artois Pharmaceutical Ind.
✅ Low Risk
FEI: 3005499067 • Tangerine • INDONESIA
FEI Number
3005499067
Location
Tangerine
Country
INDONESIAAddress
Unknown Street, , Tangerine, , Indonesia
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 |
|---|---|---|---|
| 1/18/2006 | 62UCY99ANTI-TUSSIVE/COLD N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Pt Artois Pharmaceutical Ind.'s FDA import refusal history?
Pt Artois Pharmaceutical Ind. (FEI: 3005499067) has 1 FDA import refusal record(s) in our database, spanning from 1/18/2006 to 1/18/2006.
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. Pt Artois Pharmaceutical Ind.'s FEI number is 3005499067.
What types of violations has Pt Artois Pharmaceutical Ind. received?
Pt Artois Pharmaceutical Ind. 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 Pt Artois Pharmaceutical Ind. come from?
All FDA import refusal data for Pt Artois Pharmaceutical Ind. 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.