Hill Pharmaceutical Co.,Ltd
⚠️ Moderate Risk
FEI: 3004341702 • Yongzhou, Hunan • CHINA
FEI Number
3004341702
Location
Yongzhou, Hunan
Country
CHINAAddress
128 Taoyuan West Road, Lengshuitan District, Yongzhou, Hunan, 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
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.
PLANT PART
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
UNFIT4FOOD
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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).
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).
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
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.
MELAMINE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/17/2017 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 8/17/2017 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 8/17/2017 | 54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 8/17/2017 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 10/26/2015 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 249FILTHY | Seattle District Office (SEA-DO) |
| 10/26/2015 | 54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 249FILTHY | Seattle District Office (SEA-DO) |
| 5/5/2015 | 09DGT20WHEY PRODUCTS, MODIFIED (CONDENSED, DRY) | Division of Northeast Imports (DNEI) | |
| 6/19/2014 | 54FCZ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southeast Imports (DSEI) | |
| 7/30/2009 | 54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Hill Pharmaceutical Co.,Ltd's FDA import refusal history?
Hill Pharmaceutical Co.,Ltd (FEI: 3004341702) has 9 FDA import refusal record(s) in our database, spanning from 7/30/2009 to 8/17/2017.
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. Hill Pharmaceutical Co.,Ltd's FEI number is 3004341702.
What types of violations has Hill Pharmaceutical Co.,Ltd received?
Hill Pharmaceutical Co.,Ltd has been cited for 11 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 Hill Pharmaceutical Co.,Ltd come from?
All FDA import refusal data for Hill 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.