Shenzhen Shierjie Biological Engineering Co., Ltd.
⚠️ High Risk
FEI: 3006984881 • Shenzhen, Guangdong • CHINA
FEI Number
3006984881
Location
Shenzhen, Guangdong
Country
CHINAAddress
Dongchuang Intelligent Technology Industrial Park, 1-4 Fl. Bldg. 5, No.2, Linghai Road, Kuichong Street, Dapeng, Shenzhen, Guangdong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is Shenzhen Shierjie Biological Engineering Co., Ltd.'s FDA import refusal history?
Shenzhen Shierjie Biological Engineering Co., Ltd. (FEI: 3006984881) has 1 FDA import refusal record(s) in our database, spanning from 6/18/2025 to 6/18/2025.
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. Shenzhen Shierjie Biological Engineering Co., Ltd.'s FEI number is 3006984881.
What types of violations has Shenzhen Shierjie Biological Engineering Co., Ltd. received?
Shenzhen Shierjie Biological Engineering Co., Ltd. has been cited for 3 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 Shenzhen Shierjie Biological Engineering Co., Ltd. come from?
All FDA import refusal data for Shenzhen Shierjie Biological Engineering 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.