Xiamen Origin Biotech Co. Ltd.
⚠️ High Risk
FEI: 3010307355 • Xiamen, Fujian • CHINA
FEI Number
3010307355
Location
Xiamen, Fujian
Country
CHINAAddress
NO. 7 Xiang Yue Road, Xiamen Torch, Xiamen, Fujian, 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).
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 |
|---|---|---|---|
| 2/18/2014 | 62ICT04ASPARAGINASE (ANTI-NEOPLASTIC) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 10/2/2013 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 10/2/2013 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 10/2/2013 | 65PAS04VARDENAFIL | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 9/26/2013 | 60SCT21CISAPRIDE (ANTACID) | Cincinnati District Office (CIN-DO) | |
| 9/26/2013 | 64TCT03LEVAMISOLE HYDROCHLORIDE (IMMUNOSUPPRESSIVE) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 8/5/2013 | 66SCT51TADALAFIL | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/2/2013 | 64RCR19SERMORELIN ACETATE (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64MCY04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64RCT18HUMAN GROWTH HORMONE (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64RCT18HUMAN GROWTH HORMONE (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64RCT18HUMAN GROWTH HORMONE (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64RCT19SERMORELIN ACETATE (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64RCT18HUMAN GROWTH HORMONE (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64MCY04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64RCT18HUMAN GROWTH HORMONE (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64RCT18HUMAN GROWTH HORMONE (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64RCY19SERMORELIN ACETATE (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64MCY04CHORIONIC GONADOTROPIN (GONAD-STIMULATING PRINCIPLE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64RCT19SERMORELIN ACETATE (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 65DCR06OXYTOCIN (INJECTION) (OXYTOCIC) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 66VCR99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 56OCR03MARBOFLOXACIN (FLUOROQUINOLONE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 63NCR15DEMECARIUM BROMIDE (CHOLINERGIC) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64RCR19SERMORELIN ACETATE (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 64RCS19SERMORELIN ACETATE (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 60SCT21CISAPRIDE (ANTACID) | Cincinnati District Office (CIN-DO) | |
| 8/2/2013 | 66FCY05COLCHICINE (SUPPRESSANT) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/2/2013 | 65PCT04VARDENAFIL | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/2/2013 | 66SCT51TADALAFIL | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/2/2013 | 65QCR10ALCURONIUM CHLORIDE (RELAXANT) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/2/2013 | 64RCR17ANASTROZOLE (HORMONE) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/2/2013 | 65PCT02SILDENAFIL CITRATE (REGULATOR) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/2/2013 | 61QCT03DESMOPRESSIN ACETATE (ANTI-DIURETIC) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/2/2013 | 65QCR64ROPIVACAINE HCL MONOHYDRATE (RELAXANT) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Xiamen Origin Biotech Co. Ltd.'s FDA import refusal history?
Xiamen Origin Biotech Co. Ltd. (FEI: 3010307355) has 35 FDA import refusal record(s) in our database, spanning from 8/2/2013 to 2/18/2014.
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. Xiamen Origin Biotech Co. Ltd.'s FEI number is 3010307355.
What types of violations has Xiamen Origin Biotech Co. Ltd. received?
Xiamen Origin Biotech 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 Xiamen Origin Biotech Co. Ltd. come from?
All FDA import refusal data for Xiamen Origin Biotech 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.