ERA Biotechnology (Shenzhen) Co., Ltd.
⚠️ Moderate Risk
FEI: 3010111679 • Shenzhen, Guangdong • CHINA
FEI Number
3010111679
Location
Shenzhen, Guangdong
Country
CHINAAddress
3/4 Bldgs, Donghai, Dakang Futian, Henggang Zhen Juwei Hui; Longgang, Shenzhen, Guangdong, 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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/18/2020 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Division of Southeast Imports (DSEI) | |
| 8/9/2016 | 21VCY48COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 8/9/2016 | 21VCY48COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is ERA Biotechnology (Shenzhen) Co., Ltd.'s FDA import refusal history?
ERA Biotechnology (Shenzhen) Co., Ltd. (FEI: 3010111679) has 3 FDA import refusal record(s) in our database, spanning from 8/9/2016 to 11/18/2020.
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. ERA Biotechnology (Shenzhen) Co., Ltd.'s FEI number is 3010111679.
What types of violations has ERA Biotechnology (Shenzhen) Co., Ltd. received?
ERA Biotechnology (Shenzhen) 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 ERA Biotechnology (Shenzhen) Co., Ltd. come from?
All FDA import refusal data for ERA Biotechnology (Shenzhen) 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.