Sanrace Biotechnology Co., Ltd.
⚠️ Moderate Risk
FEI: 3016897521 • Jinhua, Zhejiang • CHINA
FEI Number
3016897521
Location
Jinhua, Zhejiang
Country
CHINAAddress
268 Yanzhou Road, Lanxi, Jinhua, Zhejiang, 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
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 336INCONSPICU | Division of Northern Border Imports (DNBI) |
| 9/29/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 336INCONSPICU | Division of Northern Border Imports (DNBI) |
| 9/29/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 336INCONSPICU | Division of Northern Border Imports (DNBI) |
| 9/29/2020 | 62HBL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 336INCONSPICU | Division of Northern Border Imports (DNBI) |
| 8/28/2020 | 62FAL23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Sanrace Biotechnology Co., Ltd.'s FDA import refusal history?
Sanrace Biotechnology Co., Ltd. (FEI: 3016897521) has 5 FDA import refusal record(s) in our database, spanning from 8/28/2020 to 9/29/2020.
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. Sanrace Biotechnology Co., Ltd.'s FEI number is 3016897521.
What types of violations has Sanrace Biotechnology Co., Ltd. received?
Sanrace Biotechnology 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 Sanrace Biotechnology Co., Ltd. come from?
All FDA import refusal data for Sanrace Biotechnology 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.