Bloomage Biotechnology Corp., Ltd.
⚠️ Moderate Risk
FEI: 3008240723 • Jinan, Shandong • CHINA
FEI Number
3008240723
Location
Jinan, Shandong
Country
CHINAAddress
678 Tianchen Road, Hi-Tech Development Zone, , 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
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2020 | 78MRESOLUTION, SODIUM HYALURONATE | Division of Southeast Imports (DSEI) | |
| 8/2/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 5/30/2014 | 89MOZACID, HYALURONIC, INTRAARTICULAR | 237NO PMA | Division of Northern Border Imports (DNBI) |
| 3/6/2012 | 56YBK99ANTIBIOTIC N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/31/2011 | 54YMY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 1/22/2008 | 78MRESOLUTION, SODIUM HYALURONATE | 2380NO PMA/PDP | Los Angeles District Office (LOS-DO) |
| 5/9/2006 | 64WQP99IRRIGATION SOLUTION N.E.C. | New Orleans District Office (NOL-DO) | |
| 10/14/2003 | 78MRESOLUTION, SODIUM HYALURONATE | 16DIRECTIONS | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Bloomage Biotechnology Corp., Ltd.'s FDA import refusal history?
Bloomage Biotechnology Corp., Ltd. (FEI: 3008240723) has 8 FDA import refusal record(s) in our database, spanning from 10/14/2003 to 12/9/2020.
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. Bloomage Biotechnology Corp., Ltd.'s FEI number is 3008240723.
What types of violations has Bloomage Biotechnology Corp., Ltd. received?
Bloomage Biotechnology Corp., Ltd. has been cited for 8 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 Bloomage Biotechnology Corp., Ltd. come from?
All FDA import refusal data for Bloomage Biotechnology Corp., 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.