Coltor Nicoleta D
⚠️ Moderate Risk
FEI: 3006327531 • Alba Iulia, Alba • ROMANIA
FEI Number
3006327531
Location
Alba Iulia, Alba
Country
ROMANIAAddress
Strada Doctor Ratiu Ioan 27, , Alba Iulia, Alba, Romania
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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
Frequently Asked Questions
What is Coltor Nicoleta D's FDA import refusal history?
Coltor Nicoleta D (FEI: 3006327531) has 1 FDA import refusal record(s) in our database, spanning from 10/9/2007 to 10/9/2007.
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. Coltor Nicoleta D's FEI number is 3006327531.
What types of violations has Coltor Nicoleta D received?
Coltor Nicoleta D 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 Coltor Nicoleta D come from?
All FDA import refusal data for Coltor Nicoleta D 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.