Prothya Biosolutions Netherlands B.V.
⚠️ Moderate Risk
FEI: 3007166802 • Amsterdam, Noord-Holland • NETHERLANDS
FEI Number
3007166802
Location
Amsterdam, Noord-Holland
Country
NETHERLANDSAddress
Plesmanlaan 125, , Amsterdam, Noord-Holland, Netherlands
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 LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/16/2016 | 57UH12ALBUMIN | 71NO LICENSE | Chicago District Office (CHI-DO) |
| 7/16/2007 | 82DBACOMPLEMENT C1 INHIBITOR (INACTIVATOR), ANTIGEN, ANTISERUM, CONTROL | 237NO PMA | New Orleans District Office (NOL-DO) |
| 7/16/2007 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2005 | 89ITWJOINT, ANKLE, EXTERNAL BRACE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Prothya Biosolutions Netherlands B.V.'s FDA import refusal history?
Prothya Biosolutions Netherlands B.V. (FEI: 3007166802) has 4 FDA import refusal record(s) in our database, spanning from 1/6/2005 to 6/16/2016.
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. Prothya Biosolutions Netherlands B.V.'s FEI number is 3007166802.
What types of violations has Prothya Biosolutions Netherlands B.V. received?
Prothya Biosolutions Netherlands B.V. has been cited for 4 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 Prothya Biosolutions Netherlands B.V. come from?
All FDA import refusal data for Prothya Biosolutions Netherlands B.V. 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.