Globe Fine Chemicals Holland Bv
⚠️ Moderate Risk
FEI: 3007347074 • Rotterdam, Zuid-Holland • NETHERLANDS
FEI Number
3007347074
Location
Rotterdam, Zuid-Holland
Country
NETHERLANDSAddress
Laan Op Zuid 196-198, , Rotterdam, Zuid-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).
FEED & NAD
The article appears to be an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 512.
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.
Refusal History
Frequently Asked Questions
What is Globe Fine Chemicals Holland Bv's FDA import refusal history?
Globe Fine Chemicals Holland Bv (FEI: 3007347074) has 1 FDA import refusal record(s) in our database, spanning from 12/17/2009 to 12/17/2009.
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. Globe Fine Chemicals Holland Bv's FEI number is 3007347074.
What types of violations has Globe Fine Chemicals Holland Bv received?
Globe Fine Chemicals Holland Bv 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 Globe Fine Chemicals Holland Bv come from?
All FDA import refusal data for Globe Fine Chemicals Holland Bv 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.