Huaian Zongheng Bio-Tech Co., Ltd
⚠️ Moderate Risk
FEI: 3007628845 • Huaian, Jiangsu • CHINA
FEI Number
3007628845
Location
Huaian, Jiangsu
Country
CHINAAddress
No. 615 North Xiangyu Road, , Huaian, 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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/29/2020 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 3/11/2020 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 3/11/2020 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 2/18/2020 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 2/18/2020 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 12/19/2019 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 197COSM COLOR | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Huaian Zongheng Bio-Tech Co., Ltd's FDA import refusal history?
Huaian Zongheng Bio-Tech Co., Ltd (FEI: 3007628845) has 6 FDA import refusal record(s) in our database, spanning from 12/19/2019 to 6/29/2020.
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. Huaian Zongheng Bio-Tech Co., Ltd's FEI number is 3007628845.
What types of violations has Huaian Zongheng Bio-Tech Co., Ltd received?
Huaian Zongheng Bio-Tech Co., Ltd has been cited for 2 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 Huaian Zongheng Bio-Tech Co., Ltd come from?
All FDA import refusal data for Huaian Zongheng Bio-Tech 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.