Shanghai Hoo Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3013542961 • Meilong, Shanghai • CHINA
FEI Number
3013542961
Location
Meilong, Shanghai
Country
CHINAAddress
No. 289 Caolian Road, Meilong Town Minhang District, Meilong, 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
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 1/6/2022 | 54ACH90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | Division of Northeast Imports (DNEI) | |
| 3/18/2020 | 41BGN99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | Division of West Coast Imports (DWCI) | |
| 3/8/2010 | 54CCE05L-CYSTEINE (PROTEIN) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shanghai Hoo Pharmaceutical Co., Ltd.'s FDA import refusal history?
Shanghai Hoo Pharmaceutical Co., Ltd. (FEI: 3013542961) has 3 FDA import refusal record(s) in our database, spanning from 3/8/2010 to 1/6/2022.
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 Hoo Pharmaceutical Co., Ltd.'s FEI number is 3013542961.
What types of violations has Shanghai Hoo Pharmaceutical Co., Ltd. received?
Shanghai Hoo Pharmaceutical Co., Ltd. has been cited for 7 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 Hoo Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Shanghai Hoo Pharmaceutical 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.