Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd
⚠️ Moderate Risk
FEI: 3008519597 • Yangzhou, Jiangsu • CHINA
FEI Number
3008519597
Location
Yangzhou, Jiangsu
Country
CHINAAddress
Industrial Park, 7 Sitong Road; Hangjizhen Hanjiang, Yangzhou, Jiangsu, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2020 | 63RBZ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 9/19/2016 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Seattle District Office (SEA-DO) | |
| 9/19/2016 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Seattle District Office (SEA-DO) | |
| 8/23/2016 | 63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Seattle District Office (SEA-DO) |
| 2/25/2011 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/16/2008 | 63RNY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 238UNSAFE ADD | New York District Office (NYK-DO) |
| 4/16/2008 | 63RNY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 186INSANITARY | New York District Office (NYK-DO) |
| 2/8/2008 | 63RNY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 238UNSAFE ADD | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd's FDA import refusal history?
Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd (FEI: 3008519597) has 8 FDA import refusal record(s) in our database, spanning from 2/8/2008 to 11/20/2020.
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. Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd's FEI number is 3008519597.
What types of violations has Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd received?
Yangzhou Hengyuan Daily Chemical Plastic 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 Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd come from?
All FDA import refusal data for Yangzhou Hengyuan Daily Chemical Plastic 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.