Passiano International
⚠️ Moderate Risk
FEI: 3004588920 • Shanghai • CHINA
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
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.
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/10/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 3/22/2007 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 2/9/2007 | 54YCB99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Passiano International's FDA import refusal history?
Passiano International (FEI: 3004588920) has 3 FDA import refusal record(s) in our database, spanning from 2/9/2007 to 4/10/2007.
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. Passiano International's FEI number is 3004588920.
What types of violations has Passiano International received?
Passiano International 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 Passiano International come from?
All FDA import refusal data for Passiano International 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.