Shanghai Passiono International Co Ltd
⚠️ Moderate Risk
FEI: 3007459201 • Shanghai • CHINA
FEI Number
3007459201
Location
Shanghai
Country
CHINAAddress
1818 Huangxing Road, , 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
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.
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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/23/2014 | 78MRESOLUTION, SODIUM HYALURONATE | 333LACKS FIRM | Cincinnati District Office (CIN-DO) |
| 3/17/2014 | 65JIY31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/7/2013 | 54YBR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 1/7/2013 | 54YBS99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Cincinnati District Office (CIN-DO) |
| 10/26/2012 | 65QIY99RELAXANT N.E.C. | Cincinnati District Office (CIN-DO) | |
| 4/25/2011 | 66VCR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Shanghai Passiono International Co Ltd's FDA import refusal history?
Shanghai Passiono International Co Ltd (FEI: 3007459201) has 6 FDA import refusal record(s) in our database, spanning from 4/25/2011 to 9/23/2014.
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. Shanghai Passiono International Co Ltd's FEI number is 3007459201.
What types of violations has Shanghai Passiono International Co Ltd received?
Shanghai Passiono International Co Ltd has been cited for 5 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 Shanghai Passiono International Co Ltd come from?
All FDA import refusal data for Shanghai Passiono 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.