Anihui Helin Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3011270211 • Bozhou, Anwei • CHINA
FEI Number
3011270211
Location
Bozhou, Anwei
Country
CHINAAddress
NO 666 Huatuo Road Anhui Qiaochent, Jiaocheng Economy District, Bozhou, Anwei, 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
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.
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
UNSFDIETUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a dietary supplement or contain a dietary ingredient that renders it adulterated under section 402(a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement.
USUAL NAME
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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
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).
SACCHARLBL
The article appears to contain Saccharin, a non-nutritive sweetener, and its label or labeling fails to list it as an added ingredient.
POISONORD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance which would ordinarily render the article injurious to health. Contains:
DIET INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise 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.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/23/2021 | 21GGT05DATES (PIT FRUIT), (PIT FRUIT) | Division of West Coast Imports (DWCI) | |
| 12/6/2018 | 54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 12/6/2018 | 54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 12/6/2018 | 54FBY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of West Coast Imports (DWCI) | |
| 3/26/2018 | 21HGH16CHINESE RED DATE (JUJUBES, ZIZIPHUS JUJUBA), DRIED OR PASTE | Division of West Coast Imports (DWCI) | |
| 1/31/2018 | 21HGH16CHINESE RED DATE (JUJUBES, ZIZIPHUS JUJUBA), DRIED OR PASTE | 249FILTHY | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Anihui Helin Pharmaceutical Co., Ltd.'s FDA import refusal history?
Anihui Helin Pharmaceutical Co., Ltd. (FEI: 3011270211) has 6 FDA import refusal record(s) in our database, spanning from 1/31/2018 to 11/23/2021.
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. Anihui Helin Pharmaceutical Co., Ltd.'s FEI number is 3011270211.
What types of violations has Anihui Helin Pharmaceutical Co., Ltd. received?
Anihui Helin Pharmaceutical Co., Ltd. has been cited for 12 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 Anihui Helin Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Anihui Helin 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.