JINAN BABIO BIOTECHNOLOGY CO.,LTD.
⚠️ Moderate Risk
FEI: 3016741564 • Jinan, Shandong • CHINA
FEI Number
3016741564
Location
Jinan, Shandong
Country
CHINAAddress
Building 5 303, 1777 Da Zheng Road; Licheng, Jinan, Shandong, 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 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.
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 |
|---|---|---|---|
| 11/15/2024 | 83JSMCULTURE MEDIA, NON-PROPAGATING TRANSPORT | 508NO 510(K) | Division of Southwest Imports (DSWI) |
| 11/8/2024 | 83JSMCULTURE MEDIA, NON-PROPAGATING TRANSPORT | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 7/13/2020 | 80FMHCONTAINER, SPECIMEN | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is JINAN BABIO BIOTECHNOLOGY CO.,LTD.'s FDA import refusal history?
JINAN BABIO BIOTECHNOLOGY CO.,LTD. (FEI: 3016741564) has 3 FDA import refusal record(s) in our database, spanning from 7/13/2020 to 11/15/2024.
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. JINAN BABIO BIOTECHNOLOGY CO.,LTD.'s FEI number is 3016741564.
What types of violations has JINAN BABIO BIOTECHNOLOGY CO.,LTD. received?
JINAN BABIO 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 JINAN BABIO BIOTECHNOLOGY CO.,LTD. come from?
All FDA import refusal data for JINAN BABIO 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.