Panalife International Co. Ltd.
⚠️ Moderate Risk
FEI: 3008611488 • Taipei, Taipei - District • TAIWAN
FEI Number
3008611488
Location
Taipei, Taipei - District
Country
TAIWANAddress
No. 20, Wu-Quan 7th Road, Wu-Gu Vill, 4 F; Taipei County 248, Taiwan, Roc, Taipei, Taipei - District, Taiwan
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
Frequently Asked Questions
What is Panalife International Co. Ltd.'s FDA import refusal history?
Panalife International Co. Ltd. (FEI: 3008611488) has 2 FDA import refusal record(s) in our database, spanning from 10/5/2011 to 10/5/2011.
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. Panalife International Co. Ltd.'s FEI number is 3008611488.
What types of violations has Panalife International Co. Ltd. received?
Panalife International Co. Ltd. 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 Panalife International Co. Ltd. come from?
All FDA import refusal data for Panalife International Co. Ltd. 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.